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1 Are Thickened Are Thickened Fluids Worth the Fluids Worth the Trouble? Trouble? A Pilot, RCT of Dysphagia A Pilot, RCT of Dysphagia Management Management Dr Sue Pownall, Professor Dr Sue Pownall, Professor Pam Enderby, Professor Tim Pam Enderby, Professor Tim Hendra, Dr Michelle Marshall Hendra, Dr Michelle Marshall

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Page 1: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

1

Are Thickened Are Thickened Fluids Worth the Fluids Worth the

Trouble?Trouble?A Pilot, RCT of Dysphagia A Pilot, RCT of Dysphagia

ManagementManagement

Dr Sue Pownall, Professor Pam Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Enderby, Professor Tim Hendra,

Dr Michelle MarshallDr Michelle Marshall

Page 2: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Exploratory / Pilot TrialExploratory / Pilot Trial

AIM

To undertake a pilot study using a randomised trial design to compare the clinical effectiveness and compliance with two treatment regimes for dysphagia following stroke

The trial was a longitudinal study following the cohort over a twelve week period.

Page 3: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ObjectivesObjectives To investigate whether the treatment

intervention of thickening fluids is as good as the treatment intervention of positioning and / or swallowing strategies, in terms of episodes of chest infection, for people experiencing dysphagia following stroke.

To compare the effects of the treatment strategies a) thickening fluids and b) positioning and / or swallowing strategy on fluid intake.

To investigate compliance of patients and carers with each treatment strategy.

Page 4: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

MethodMethod

Cohort of 50 patients admitted into Sheffield Teaching Hospitals with a diagnosis of Stroke

Referred to the SLT Department with a diagnosis of dysphagia

Cohort was selected on a consecutive basis from date of referral.

Page 5: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Exclusion CriteriaExclusion Criteria

Patients presenting with moderate or severe receptive dysphasia (as a result of their inability to comply with the treatment instructions necessary if they were randomly assigned to Group B in the study)

Patients were also excluded if they are unable to give informed consent.

Page 6: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

RandomisationRandomisation

Group A 16 patients whose dysphagia was managed by using thickened fluids

Group B 16 patients whose dysphagia was managed by postural methods or swallowing strategies.

Group C Cohort of 18 patients, who were deemed as having a safe and efficient swallow for fluids and who were recommended to have normal fluids

After initial assessment by the SLT, patients were randomly assigned to one of two treatment groups (A and B)

Page 7: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Intervention Group AIntervention Group A

Normal dense Coating consistency (Stage 1) Thick drinking consistency (Stage 2) Spooning consistency (Stage 3)

National Descriptors

Modification to the fluids

Page 8: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Intervention Group BIntervention Group B

Postural eg chin tuck, head rotation, head turn

Swallowing Strategies eg supraglottic swallow, Mendelsohn manoeuvre, effortful swallow, super-supraglottic swallow, double swallow

Postural and / or swallowing strategies

Page 9: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

OutcomesOutcomes Number of episodes of diagnosed chest

infection by the medical team over the twelve week intervention period.

Episodes of dehydration.

Compliance of the patient and carers with the treatment strategy using observational techniques by a research assistant.

Page 10: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

PRIMARY OUTCOMEPRIMARY OUTCOMECHEST INFECTIONCHEST INFECTION

a) Increased temperature >100.5 F (37.4o C) b) Increased sputum production, colour /

quantity c) Sputum culture d) Elevated white blood cell count (12x109/litre

or above) e) C-Reactive Protein f) Auscultatory findings (crepitations or signs of

consolidation) g) X-ray abnormality indicating infection

Defined as the presence of three or more of the following measures, one of which must be ‘b, c, f or g’,

Page 11: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

SECONDARY OUTCOMESECONDARY OUTCOMEEPISODES OF DEHYDRATIONEPISODES OF DEHYDRATION

No one marker of dehydration thus group of markers used, in a similar way to measures used to identify the chest infection measures, to gain content validity.

The agreed markers were:

a) Urea and electrolyte b) Serum sodium c) Osmolarity

Subtle changes across the individual were noted and assumptions made from the whole picture. In order to determine whether an individual patient showed signs of dehydration, consensus was sought from two medical physicians specialising in stroke medicine.

Page 12: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ComplianceCompliance Patients were observed on a daily basis when taking one drink Patient and staff were unaware that they were being observed

but were aware of the presence of the research assistant at that particular time.

Group A- compliance with the specific thickness of fluid was noted. This was recorded as ‘patient’ compliance if the individual thickened their own drinks or ‘nurse’ compliance if the nurses were thickening the drinks. Patient refusal to have their drinks thickened was also noted.

Group B- Non- compliance was recorded if:• the patient was not using the correct postural / swallowing

strategy For both groups non-compliance was also recorded if:

• ‘supervision’ by the nursing staff was not given although recommended as part of the intervention by the SLT

• patient had not been positioned in an upright posture when this had been recommended

Page 13: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ResultsResultsPopulationPopulation

50 patients were recruited to the study during 7 month period (Sept 2006-March 2007)

31 (62%) of the patients were female and 19 (38%) were male

Age span ranged from 48 – 98 years with a mean of 75.72 years, median 76.5 years and a mode of 75 years.

Page 14: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ResultsResultsDysphagia DiagnosisDysphagia Diagnosis

Group A differed significantly from Group C p=0.007 Group A was not significantly different to Group B

p=>0.05 Group B was not significantly different to Group C

p= >0.05 Two treatment groups were not significantly different

in terms of severity for dysphagia

Group A Group B Group COral stage 0 2 7Pharyngeal stage 1 3 3Both 15 11 8Total 16 16 18

Page 15: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Group A InterventionGroup A Intervention

12 patients were recommended to have coating consistency fluids (Stage 1)

4 were recommended to have thick drinking consistency (Stage 2)

No patients were recommended to have spooning consistency fluids (Stage 3)

Page 16: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Group B InterventionGroup B Intervention

Swallow / postural strategy Number of patients n=16

Chin tuck and small sips 6

Chin tuck only 1

Chin tuck, small sips and head rotation 1

Chin tuck, small sips and effortful swallow 1

Chin tuck, small sips and sit bolt upright 1

Small sips and sit bolt upright 1

Small sips and supervision 1

Small sips only 1

Water only with head rotation and small sips 1

Water only with double swallow and small sips 1

Water only, small sips and supervision 1

Normal fluids plus:Normal fluids plus:

Page 17: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Group C InterventionGroup C Intervention

As Group C participants were deemed as not being dysphagic for fluids they were recommended to have normal consistency fluids.

Page 18: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Outcomes (chest infection, dehydration and Outcomes (chest infection, dehydration and mortality) for 12 week study period for the mortality) for 12 week study period for the three groups (N=50)three groups (N=50)

*p-value from Chi Square

A B C Total p value *

Chest Infection

% (n/N)

25% (4/16)

31% (5/16)

28% (5/18)

28% (14/50)

0.925

Dehydration

% (n/N)

44% (7/16)

31% (5/16)

22% (4/18)

32% (16/50)

0.405

Mortality

% (n/N)

38% (6/16)

25% (4/16)

11% (2/18)

24% (12/50)

0.197

Page 19: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Outcomes (chest infection, dehydration, Outcomes (chest infection, dehydration, compliance and mortality) for 12 week study compliance and mortality) for 12 week study period for the two intervention groups A and period for the two intervention groups A and

B (N=32)B (N=32)

A B

Difference inrate

(95% CI) p value *

Chest Infection 25% 31%-6%

(-35% to 24%) 0.694

Dehydration 44% 31%13%

(-19% to 41%) 0.465

Overall compliance 31% 44%-13%

(-41% to 19%) 0.465

Mortality 38% 25%13%

(-19% to 41%) 0.446*p-value from Chi Square

Page 20: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Investigative DataInvestigative Data

Impact of ability to self feed on the health outcomes

Impact of ability to sit upright on the health outcomes

Page 21: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Impact of ability to self feed on the main health outcomes

42 patients (84%) from the total cohort were able to self feed

Ability to Self Feed n=50

Yes No

Difference inRate

(95% CI) p value *

Chest Infection

% (n/N) 21% (9/42) 63% (5/8)-41%

(-67% to -6%) 0.018 Dehydration % (n/N) 31% (13/42) 38% (3/8)

-7%(-41% to 22%) 0.716

Mortality % (n/N) 17% (7/42) 63% (5/8)

-46%(-71% to -11%) 0.005

*p-value from Chi Square

Page 22: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Impact of ability to sit upright on the main health outcomes

29 patients (58%) of the cohort were able to sit upright 29 patients (58%) of the cohort were able to sit upright

Ability to Sit Upright n=50

Yes No

Difference inRate

(95% CI) p value *

Chest Infection

% (n/N) 24% (7/29) 33% (7/21)-9%

(-34% to 15%) 0.475 Dehydration % (n/N) 31% (9/29) 33% (7/21)

-2%(-28% to 22%) 0.863

Mortality % (n/N) 3% (1/29) 52% (11/21)

-49%(-68% to -25%) 0.0001

*p-value from Chi Square

Page 23: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ConclusionsConclusionsDevelopment of Chest Infection

No evidence of a statistical difference in the development of chest infections between the two treatment groups

If a patient was unable to self feed they were statistically more likely to develop a chest infection

No statistical evidence to show that if a patient was unable to sit upright they are more at risk of developing a chest infection

Page 24: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ConclusionsConclusionsDevelopment of Dehydration

No evidence of a statistical difference in the development of dehydration between the two treatment groups

If a patient was unable to self feed they were not at statistically more risk of becoming dehydrated

No statistical evidence to show that if a patient was unable to sit upright they were more at risk of becoming dehydrated

Page 25: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ConclusionsConclusions

Compliance

Compliance of patients’ recommended thickened fluids was no worse than for patients recommended the postural / swallowing strategies

Staff were less compliant with the recommendation for thickened fluids than the patients were themselves

Page 26: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Final ThoughtsFinal Thoughts Implementation of either fluid modification or

postural/ swallowing strategies, for patients with dysphagia for fluids following stroke may be associated with a reduction in the development of chest infections

The latter strategies in particular, may result in better hydration for the patients

It is difficult to determine the exact contribution of these dysphagia specific interventions as opposed to other aspects of the patient management eg ability to self-feed / adherence to intervention

Page 27: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

An investigation into the effects An investigation into the effects of neuro-muscular electrical of neuro-muscular electrical

stimulation (NMES) on stimulation (NMES) on swallowing function in patients swallowing function in patients

presenting with persistent presenting with persistent dysphagia dysphagia

Dr Sue PownallDr Sue PownallSheffield Teaching Hospitals NHS Foundation Sheffield Teaching Hospitals NHS Foundation

TrustTrust

This study was jointly funded by:This study was jointly funded by:Devices for Dignity, Sheffield UK and AMPCARE LLC, Devices for Dignity, Sheffield UK and AMPCARE LLC,

Texas USATexas USA

Page 28: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

BackgroundBackground

Reduced or delayed hyo-laryngeal Reduced or delayed hyo-laryngeal elevation is the most common cause of elevation is the most common cause of dysphagia & aspiration (Burnett, dysphagia & aspiration (Burnett, Mann, Cornell, & Ludlow 2003).Mann, Cornell, & Ludlow 2003).

2 Patients Swallowing Under Fluoroscopy 2 Patients Swallowing Under Fluoroscopy (VF)(VF)

Compromisedhyo-laryngeal elevation

Normal hyo-laryngeal elevation

Aspiration – inhaling foreign Aspiration – inhaling foreign materialmaterial

Normal swallowNormal swallow

Page 29: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

BackgroundBackground

It has been hypothesized that electrical It has been hypothesized that electrical stimulation can assist hyo-laryngeal stimulation can assist hyo-laryngeal elevation (Freed et al 2001; Leelamanit et elevation (Freed et al 2001; Leelamanit et al 2002).al 2002).

Stimulation of laryngeal elevation Stimulation of laryngeal elevation musculature via NMES in combination with musculature via NMES in combination with traditional treatments is suggested to re-traditional treatments is suggested to re-educate these muscles when suffering from educate these muscles when suffering from reduced laryngeal elevation.reduced laryngeal elevation.

Successful swallowing therapy is essential Successful swallowing therapy is essential to improve the health status and the quality to improve the health status and the quality of life in people with dysphagia.of life in people with dysphagia.

Page 30: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Muscles and Muscle Muscles and Muscle Groups Groups

of Interestof Interest Suprahyoid muscle group:Suprahyoid muscle group:

elevate & protract hyoidelevate & protract hyoidAnterior bellyAnterior belly

of Digastricof Digastric

MylohyoidMylohyoid

GeniohyoidGeniohyoid

elevate & retract hyoidelevate & retract hyoid

StylohyoidStylohyoid Posterior bellyPosterior belly

of Digastricof Digastric

Page 31: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

NMES TechnologyNMES Technology The RxThe Rx33ESPESP®®

(Effective Swallowing (Effective Swallowing Protocol) utilizes a Protocol) utilizes a portable electrical portable electrical muscle stimulator muscle stimulator that works by that works by applying pulsed applying pulsed electrical current electrical current through electrodes through electrodes on the skin to on the skin to depolarize nerve depolarize nerve endings and produce endings and produce a muscle contraction.a muscle contraction.

Rx3E Electrodes

Lead wires

Rx3ES Unit

Rx3P (Posture Device)

Page 32: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Larynx Larynx Larynx with Larynx with at rest at rest RxRx33ESPESP

Page 33: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Purpose Purpose

To investigate the effects of NMES To investigate the effects of NMES of the laryngeal elevation of the laryngeal elevation musculature on swallowing musculature on swallowing function in patients presenting with function in patients presenting with persistent dysphagia (3 months or persistent dysphagia (3 months or greater of non progressive greater of non progressive dysphagia status to rule out the dysphagia status to rule out the variable of spontaneous recovery).variable of spontaneous recovery).

Aim: To increase oral nutrition and Aim: To increase oral nutrition and hydration by improving swallow hydration by improving swallow function and safety.function and safety.

Page 34: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Inclusion CriteriaInclusion Criteria

Adults with a diagnosis of persistent, Adults with a diagnosis of persistent, non progressive dysphagia (greater non progressive dysphagia (greater than 3 months since diagnosis to rule than 3 months since diagnosis to rule out the variable of spontaneous out the variable of spontaneous recovery) where decreased laryngeal recovery) where decreased laryngeal elevation is a key feature of the elevation is a key feature of the disorder, diagnosed by disorder, diagnosed by videofluoroscopy examination.videofluoroscopy examination.

Page 35: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Exclusion Criteria Exclusion Criteria

Adults who had an implanted electronic device e.g. Adults who had an implanted electronic device e.g. Pacemaker.Pacemaker.

Adults presenting with moderate or severe receptive Adults presenting with moderate or severe receptive aphasia (a language disorderaphasia (a language disorder occurring as a result of occurring as a result of CVA), and/or cognitive impairment. These people CVA), and/or cognitive impairment. These people were excluded as a result of the increased likelihood were excluded as a result of the increased likelihood of their inability to comply with the treatment of their inability to comply with the treatment instructions. instructions.

Patients who were unable to give informed consent.Patients who were unable to give informed consent. Patients presenting with progressive diseases.Patients presenting with progressive diseases. Patients who were pregnant.Patients who were pregnant. Patients who had active cancerous lesions or Patients who had active cancerous lesions or

infections which were present in the treatment area.infections which were present in the treatment area.

Page 36: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

MethodMethod 8 Sheffield SLT’s were trained in the principles of 8 Sheffield SLT’s were trained in the principles of

NMES and the use of the RxNMES and the use of the Rx33ESPESP Feasibility study using a case series which Feasibility study using a case series which

included 5 patients with stable and persistent included 5 patients with stable and persistent dysphagia who presented with decreased dysphagia who presented with decreased laryngeal elevation diagnosed by laryngeal elevation diagnosed by Videofluoroscopy (VF).Videofluoroscopy (VF).

Participants received 4 weeks of daily Participants received 4 weeks of daily intervention (5 days per week for 30 minutes intervention (5 days per week for 30 minutes based on the Rxbased on the Rx33ESP). Participant’s swallowing ESP). Participant’s swallowing was re-assessed by VF and clinical assessment was re-assessed by VF and clinical assessment post intervention. A follow-up assessment was post intervention. A follow-up assessment was completed two weeks after completion of the completed two weeks after completion of the intervention.intervention.

Page 37: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

MethodMethod The ethical committee giving consent for the The ethical committee giving consent for the

study had requested that those patients who study had requested that those patients who wanted to continue with the intervention after the wanted to continue with the intervention after the 4 weeks study period should be offered further 4 weeks study period should be offered further intervention if possible.intervention if possible.

Patients 2, 3, and 4 continued with the Patients 2, 3, and 4 continued with the intervention for an added 2 weeks with the intervention for an added 2 weeks with the intervention three times per week. These patients intervention three times per week. These patients underwent a further VF procedure one week later.underwent a further VF procedure one week later.

Patients 1 and 5 were followed up 2 weeks after Patients 1 and 5 were followed up 2 weeks after completion in the study (without further completion in the study (without further intervention or further VF) to gain qualitative intervention or further VF) to gain qualitative data on their progress.data on their progress.

Page 38: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ProcedureProcedure

Initially the intensity of current was Initially the intensity of current was slowly increased to maximum slowly increased to maximum tolerance, according to patients tolerance, according to patients feedback. Maximum tolerance was feedback. Maximum tolerance was defined as the level of motor defined as the level of motor contraction of the muscles reported as contraction of the muscles reported as a “grabbing” sensation by the patient a “grabbing” sensation by the patient without being painful. without being painful.

Inte

nsity

Sensation “Tingling” “Vibration” “Grabbing”

Inte

nsity

Sensation “Tingling” “Vibration” “Grabbing”

Page 39: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Procedure Procedure

To lessen the chance of current To lessen the chance of current accommodation the SLT’s were accommodation the SLT’s were instructed to ask the patient two times instructed to ask the patient two times during the course of each session if during the course of each session if they could tolerate more intensity (i.e. they could tolerate more intensity (i.e. after the initial 10 minutes and 20 after the initial 10 minutes and 20 minutes of the 30 minute session).minutes of the 30 minute session).

Patients were asked to perform the Patients were asked to perform the following 3 exercises for 10 minutes following 3 exercises for 10 minutes each during stimulation “on” times:each during stimulation “on” times:1.1. Modified Shaker into the RxModified Shaker into the Rx33P for 4 P for 4

seconds followed by a swallow.seconds followed by a swallow.2.2. Mendelsohn Maneuver for 4 seconds Mendelsohn Maneuver for 4 seconds

followed by a swallow.followed by a swallow.3.3. Effortful Swallow.Effortful Swallow.

Page 40: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Procedure Procedure Exercise and NMES Duty Cycle ProgressionExercise and NMES Duty Cycle Progression

Week 1 – Duty cycle will be 5 seconds on and Week 1 – Duty cycle will be 5 seconds on and 25 seconds off for a total of 60 stimulations 25 seconds off for a total of 60 stimulations (i.e. 20 Shaker, 20 Mendelsohn, 20 Effortful)(i.e. 20 Shaker, 20 Mendelsohn, 20 Effortful)

Week 2 – Duty cycle will be 5 seconds on and Week 2 – Duty cycle will be 5 seconds on and 20 seconds off for a total of 72 stimulations20 seconds off for a total of 72 stimulations

(i.e. 24 Shaker, 24 Mendelsohn, 24 Effortful)(i.e. 24 Shaker, 24 Mendelsohn, 24 Effortful)

Week 3-4 – Duty cycle will be 5 seconds on Week 3-4 – Duty cycle will be 5 seconds on and 15 seconds off for a total of 90 and 15 seconds off for a total of 90 stimulationsstimulations

(i.e. 30 Shaker, 30 Mendelsohn, 30 Effortful)(i.e. 30 Shaker, 30 Mendelsohn, 30 Effortful)

Page 41: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Outcome MeasuresOutcome Measures Data was collected using the:Data was collected using the:

1.1. Functional Oral Intake Scale (FOIS)Functional Oral Intake Scale (FOIS)

2.2. Rosenbek Penetration/aspiration scaleRosenbek Penetration/aspiration scale

3.3. Waxman Dysphagia severity scaleWaxman Dysphagia severity scale Patients also completed a questionnaire Patients also completed a questionnaire

about their experiences and the about their experiences and the acceptability of the intervention.acceptability of the intervention.

SLT’s attended a group interview to discuss SLT’s attended a group interview to discuss the use of the device and protocol.the use of the device and protocol.

Data was analyzed using descriptive Data was analyzed using descriptive statistics under the guidance of a medical statistics under the guidance of a medical statistician. statistician.

Page 42: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ResultsResults 5 patients were recruited to the study 5 patients were recruited to the study

during June of 2011.during June of 2011. All were male and ages ranged from 59-78 All were male and ages ranged from 59-78

years.years. All patients were PEG dependent and the All patients were PEG dependent and the

length of persistent dysphagia ranged from length of persistent dysphagia ranged from 3 months to two years.3 months to two years.

All participants completed 20 sessions, All participants completed 20 sessions, described the intervention as acceptable described the intervention as acceptable and would strongly recommend it to others.and would strongly recommend it to others.

Patient Diagnosis Age1 CVA Right PICA February 2011 69

2 Tonsillar Cancer Neck Dissection Left Side 2009

59

3 CVA Right MCA 2009 78

4 Right Glomus Jugular Tumor 2009 71

5 Left Skull Base Osteomyelitis with Left Vocal Cord Palsy 2009

65

Page 43: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ResultsResults All 5 participants showed improvements in All 5 participants showed improvements in

their swallowing to varying degrees.their swallowing to varying degrees. 2 participants returned to full oral diet having 2 participants returned to full oral diet having

been on non-oral feeding for 5 months and been on non-oral feeding for 5 months and over 24 months respectively, although one over 24 months respectively, although one continued to show aspiration with some continued to show aspiration with some intake. Both ceased nutritional intake via PEG intake. Both ceased nutritional intake via PEG reducing costs to the NHS.reducing costs to the NHS.

3 patients introduced an increased amount 3 patients introduced an increased amount and range of food consistencies to their oral and range of food consistencies to their oral intake, although they continue to receive their intake, although they continue to receive their main nutrition via PEG.main nutrition via PEG.

Page 44: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Rosenbek Rosenbek Penetration/Aspiration Scale Penetration/Aspiration Scale

LiquidsLiquids

Post 4 week interventionPost 4 week intervention The two patients with a diagnosis of Stroke The two patients with a diagnosis of Stroke

showed improvements in the levels of showed improvements in the levels of aspiration/penetration occurring during aspiration/penetration occurring during liquid swallows (Patients 1 & 3)liquid swallows (Patients 1 & 3)

Patient 4 showed a worse score with Patient 4 showed a worse score with liquids however on the post intervention liquids however on the post intervention VF he was feeling unwell and by the follow-VF he was feeling unwell and by the follow-up he was taking larger sips on the follow-up he was taking larger sips on the follow-up VF. Scores with these ranged from 1-7 up VF. Scores with these ranged from 1-7 so amount of aspiration is variable.so amount of aspiration is variable.

Page 45: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

Rosenbek Rosenbek Penetration/Aspiration Scale Penetration/Aspiration Scale

SolidsSolidsPost 4 week interventionPost 4 week intervention Two patients who were deemed from clinical Two patients who were deemed from clinical

decisions to be unsafe to try solid diet on the first decisions to be unsafe to try solid diet on the first VF examination went on to swallow these on the VF examination went on to swallow these on the post intervention VF (Patients 2, & 5).post intervention VF (Patients 2, & 5).

Follow-upFollow-up Patient 2 showed an improvement in penetration Patient 2 showed an improvement in penetration

levels with both liquid and solid swallowslevels with both liquid and solid swallows Patient 4 was assessed with solid which had been Patient 4 was assessed with solid which had been

deemed from clinical decision at the first two VFs deemed from clinical decision at the first two VFs to be unsafe.to be unsafe.

Page 46: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ResultsResults Patient description of daily oral intakePatient description of daily oral intake Patient 1Patient 1 - - Pre - 5 teaspoons fluid or 5 teaspoons soft fork mashed diet at any one sittingPre - 5 teaspoons fluid or 5 teaspoons soft fork mashed diet at any one sitting..

Post - Sips fluid and small amounts soft dietPost - Sips fluid and small amounts soft diet..

Follow-up - Eating full oral intake. PEG to be removed. Follow-up - Eating full oral intake. PEG to be removed. 

Patient 2Patient 2 - - Pre - Half pint soup taken in small amounts throughout day.Pre - Half pint soup taken in small amounts throughout day.

Post - As above plus half a cup of coffee. Sometimes able to drink a whole cup in one sitting.Post - As above plus half a cup of coffee. Sometimes able to drink a whole cup in one sitting.

Follow-up - As above plus 4x half cup coffee per day. Introducing small amount soft fork Follow-up - As above plus 4x half cup coffee per day. Introducing small amount soft fork mashable mashable

foods.foods.

Patient 3Patient 3 - - Pre - small amounts normal diet and fluids.Pre - small amounts normal diet and fluids.

Post - increased amount of oral intake. PEG feed has been reduced to 1 litre from 2 litres intake.Post - increased amount of oral intake. PEG feed has been reduced to 1 litre from 2 litres intake.

Follow-up - Full oral intake. Flushing PEG only to keep patent.Follow-up - Full oral intake. Flushing PEG only to keep patent.

Patient 4Patient 4 - - Pre - 2-4 cups tea per day.Pre - 2-4 cups tea per day.

Post - as above but easier to swallow and less coughing occurringPost - as above but easier to swallow and less coughing occurring

Follow-up - intermittently eating minimal amounts soft fork mashed diet. First solid food in 3 Follow-up - intermittently eating minimal amounts soft fork mashed diet. First solid food in 3 years.years.

Patient 5Patient 5 - - Pre- Water only sucked from mouth sponges.Pre- Water only sucked from mouth sponges.

Post- Sips water, plus small amount soft fork mashed dietPost- Sips water, plus small amount soft fork mashed diet

Follow-up- as aboveFollow-up- as above

Page 47: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

ConclusionConclusion

Results suggest this technique may Results suggest this technique may be an effective intervention for some be an effective intervention for some patients presenting with persistent patients presenting with persistent dysphagia.dysphagia.

A pilot study is now planned to A pilot study is now planned to investigate the technique using a investigate the technique using a randomized design.randomized design.

Page 48: 1 Are Thickened Fluids Worth the Trouble? A Pilot, RCT of Dysphagia Management Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle

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Rosenbek JC, Robbins JA, Roecker EB, Coyle JL & Wood JL. Rosenbek JC, Robbins JA, Roecker EB, Coyle JL & Wood JL. A penetration-aspiration scale. A penetration-aspiration scale. Dysphagia, Spring; Dysphagia, Spring; 11(2): 93-8, 11(2): 93-8, 1996.1996.