prospective randomized controlled multi-centre trial of cuffed or uncuffed ett in small children

8/7/2019 Prospective Randomized Controlled Multi-centre Trial of Cuffed or Uncuffed Ett in Small Children

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Background

y The use of cuffed tracheal tubes (TTs) in smallchildren is still controversial.

y The aim of this study was to compare post-extubationmorbidity and TT exchange rates when using cuffed vsuncuffed tubes in small children.



Methods.

y Patients were prospectively randomized into a cuffedTT group (Microcuff® PET) and an uncuffed TT group

(Mallinckrodt®,P

ortex®, Rsch®, Sheridan®).



Inclusion cri

teria

y Children aged from birth (weighing 3 kg) to < 5 yr

y Children requiring oro-tracheal or naso-tracheal intubation with aMagill shaped TT or preformed (RA E) TT as a part of their anaestheticcare and planed controlled ventilation during the

surgical/interventional/diagnostic procedurey Tracheal intubation performed using direct laryngoscopy

y Extubation after the procedure in the operating theatre

y Procedure performed in the supine position

y Patients for elective and emergency surgery, interventions, or both if there is no risk for regurgitation or pulmonary aspiration

y ASA physical status I and II

y Written parental consent



Exclusion criteria

y No parental written consent obtainedy Known airway anomalies (airway stenosis, including Downs syndrome)y Known or suspected difficult intubationy Known need for abnormal tube sizey

Children at risk for regurgitationy Surgery of the larynx and/or of the trachea, neck, and/or upper

oesophagusy Pulmonary diseases (concurrent pneumonia or bronchial infection,

asthma requiring inhalation medication, pulmonary malformations)y ASA physical status > IIy

Fibreoptic intubation or alternative intubation techniquey Planned postoperative ventilation in the ICUy Weight and/or height percentiles <3%/ >97%



Fi 1 Test asse ly se i the c ffe r : c ffe ae iatric TT( icr c ff PET) attache t a c ff ress re a eter ith ress re

release valve (arr ) li iti c ff ress re at 20 c 2O.



Methodsy Endpoints were incidence of post-extubation stridor

and the number of TT exchanges to find anappropriate-sized tube.

y

For cuffed TTs, minimal cuff pressure required to sealthe airway was noted; maximal cuff pressure waslimited at 2 cm H2 with a pressure release valve.

y Data are mean (SD).



Data management and statistical analysis

y Completed data forms were copied at the local centreand the original data forms sent to the organizers and

checked.y All analyses have been calculated using SAS (Version

.2, SAS Inc., Cary, NC, USA) or SPSS (Version 1 ,SPSS Inc., Chicago, IL, USA).



Results

y 4 study envelopes were sent to the study centres.

y Due to manufacturer problem of TT, the study was

stopped ahead of schedule.y A total of 2406 completed data forms were returned

from the study centres.

y 160 data forms (106 in the cuffed group/54 in the

uncuffed group) had to be excluded because the agegroup or the TT size with regard to age group was notcorrectly selected.



Results

y Finally, 2246 children from 24 study centres wereinvestigated (1119/1127 cuffed/uncuffed tubes).

y5 patients (1 in the cuffed group/4 in the uncuffedgroup) remained intubated after operation and werenot included in the assessment of post-intubationmorbidity.

yNumbers of patients investigated per centre rangedfrom 7 to 1 ; median 3 patients



Results

y Childrens age was 1.93 (1.48) yr in the initially cuffed(n=1119) and 1.87 (1.45) yr in the initially uncuffed

(n=1127) study groups.



Results



Results

y Post-extubation stridor was noted in 4.4% in the finalcuffed group and in 4.7% in the final uncuffed group

(P

=0.543, risk ratio 0.936)y Exclusion of patients with one or several tube

exchanges did not significantly alter post-extubationmorbidity among the two groups



Results



Results

y TT exchange rate was 2.1% in the cuffed and 30.8% inthe uncuffed study groups (P<0.0001, risk ratio 0.068).

y

Minimal cuff pressure to seal the trachea in the cuffedgroup was 10.6 (4.3) cm H2 .



Results



Results

y Intraoperatively, capnography was reliable in 98.6%(cuffed TTs) and in 95.6% (uncuffed TTs) (P<0.0001,

risk ratio 1.03)



Results



Discussiony Why the incidence of post-extubation stridor was not

affected by the use of cuffed TTs ?

- An anatomically designed high volume- low pressuretube cuff

- A controlled and limited cuff pressure was used

- The tube size selected strictly according to size

recommendations.



Discussiony Cuffed tubes were selected with a smaller diameter,

and the cuff was inflated as required to fill theindividual gap between the tube and the tracheal wall

15 times reduced need for TT changes

less use of throat packaging

y to find an appropriate TT at the first attempt was97.9% for cuffed and only 69.5% for uncuffed TTs.



Discussiony The cuff inflation pressure (10.6 cm H2 ) needed to

accomplish an adequate tracheal seal was substantially

less than with other paediatric TT cuffs

y The better tracheal seal by the TT cuff result in areliable capnography trace



Conclusions.y The use of cuffed TTs in small children provides

- a reliably sealed airway at cuff pressures of 20 cm H2 ,

- reduces the need for TT exchanges,- does not increase the risk for post-extubation stridor

compared with uncuffed TTs.

prospective randomized controlled multi-centre trial of cuffed or uncuffed ett in small children

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