"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
- Conditions
- Need for Tracheal Tube ExchangePresence of Post-extubation Laryngeal Oedema
- Registration Number
- NCT00221377
- Lead Sponsor
- University Children's Hospital, Zurich
- Brief Summary
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
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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4000
- 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
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method post-extubation stridor (airway stenosis)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Anaesthesia - Chelsa and Westminster NHS Trust
🇬🇧London, United Kingdom
Klinik für Anaesthesie, LMU München - Dr. U. Haunersches Kinderspital
🇩🇪München, Germany
Dept. of Anaesthesia - Kinderkrankenhaus auf der Bult
🇩🇪Hannover, Germany
Anaesthesia - Klinik St. Hedwig
🇩🇪Regensburg, Germany
Dept. of Anaesthesia Kliniken Loerrach
🇩🇪Loerrach, Germany
Anaesthesia and Intensive Care - University Hospital Mannheim
🇩🇪Mannheim, Germany
Anaesthetics - Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, United Kingdom
Dep. Anesthesiology and Intensive Care - Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Anaesthetic Department - Royal Hospital for Sick Children
🇬🇧Glasgow, United Kingdom
Anaesthetic Department - Ledds General Infirmary
🇬🇧Leeds, United Kingdom
Clinic of Anesthesiology - Charite-Universitätsmedizin
🇩🇪Berlin, Germany
Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg
🇩🇪Augsburg, Germany
Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital
🇸🇪Stockholm, Sweden
Anästhesie - Ostschweizer Kinderspital
🇨ðŸ‡St. Gallen, Switzerland
University Children's Hospital
🇨ðŸ‡Zurich, ZH, Switzerland
Klinik für Anästhesiologie - Inselspital
🇨ðŸ‡Bern, Switzerland
Departement of Anaesthesia - Cliniques Universitaire St. Luc
🇧🇪Brussels, Belgium
Dept. of Anaesthesia and Reanimation - University Hospital Motol
🇨🇿Prague, Czech Republic
Children's University Hospital - Dept. of Anaesthesia and Intensive Care
🇸🇰Bratislava, Slovakia
Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur
🇸🇰Kosice, Slovakia
Klinik für Anästhesie und Op. Intensivmedizin
🇨ðŸ‡Aarau, Switzerland
Dept. of Anaesthesia, Geneva Children's Hospital
🇨ðŸ‡Geneva, Switzerland
Anesthesia And Critical Care Medicine - Medical University
🇦🇹Innsbruck, Austria
Service d'Anesthesiologie - CHUV
🇨ðŸ‡Lausanne, Switzerland