Cuffed Versus Uncuffed Tracheal Tubes in Small Children

Study Overview
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Brief Summary
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This randomized controlled multi-centre trial in children from birth up to < 5 years of age aims to demonstrate equivalence as to the major outcome of post-extubation airway injury (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume - low pressure cuff combined with a cuff pressure release valve.

Detailed Description
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The use of cuffed tracheal tubes is a controversial topic in paediatric anaesthesia and intensive care medicine. Cuffed tubes have traditionally been recommended for children older than 8 to 10 years. During the past decade, however, several authors have argued for the use of cuffed tracheal tubes in younger children and infants. A frequently cited argument against their use is the fear from post-extubation morbidity, allegedly caused by cuff induced tracheal and laryngeal airway injury. Using modern improved designed cuffed tracheal tubes, data from randomised prospective studies, performed in paediatric anaesthesia and intensive care units, suggest that using cuffed tracheal tubes do not carry an increased risk for airway morbidity as compared to uncuffed tracheal tubes in children below 8 years of age if correctly used. However, all these studies are based on single-centre experiences and/or included only a few neonates, infants and small children. Hence, there is equipoise as to the question, whether cuffed tubes are preferable over uncuffed standard tubes. So, this randomized controlled multi-centre trial in children from birth up to < 5 years of age aims to demonstrate equivalence as to the major outcome of post-extubation airway injury (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume - low pressure cuff combined with a cuff pressure release valve. The primary hypothesis relates to the main outcome criteria of this study, which is post-extubation morbidity as measured by the presence or absence of stridor after tracheal extubation. The null-hypothesis Ho is defined as no difference in the incidence rates of post-extubation morbidity between cuffed and uncuffed groups. The null-hypothesis (Ho: u-Diff = 0) will be compared with the alternative hypothesis (H1: u-Diff <> 0). The study is designed to detect a clinically unacceptable deterioration of 1.5% above the baseline airway-injury rate of 2.5% when using uncuffed tubes with a power of 90% and a type I error probability of less than 5%.

Official Title
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Cuffed Versus Uncuffed Tracheal Tubes in Small Children

Conditions
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Need for Tracheal Tube Exchange, Presence of Post-extubation Laryngeal Oedema

Intervention / Treatment
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* Device: Intubation using tracheal tubes with or without cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged from birth (weighing > 3 kg) to <5 years Children requiring oro-tracheal or naso-tracheal intubation with a Magil shaped tracheal tube or preformed (RAE) tracheal tube as a part of their anaesthetic care and planed IPPV during the surgical / interventional / diagnostic procedure Tracheal intubation performed using direct laryngoscopy Extubation after the procedure in the OR theatre Procedure performed in supine position Patients for elective and emergency surgery and/or interventions if there is no risk for regurgitation or pulmonary aspiration ASA I and II patients Written parental consent Exclusion Criteria: No parental written consent obtained Known airway anomalies (airway stenosis, including Down's Syndrome) Known or suspected difficult intubation Known need for abnormal tube size Full stomach and/or at risk for regurgitation Surgery of the larynx and/or of the trachea and/or neck and/or upper oesophagus Pulmonary diseases (concurrent pneumonia or bronchial infection, asthma requiring inhalation medication, pulmonary malformations) ASA class III and higher Fiberoptic intubation or alternative intubation technique Patients planned for postoperative ventilation in the ICU Weight and/or height percentiles < 3% / > 97%

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intubation using tracheal tubes with or without cuff|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-extubation stridor (airway stenosis) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trachea, intubation, tube, cuff, children