Status:
COMPLETED
"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
Lead Sponsor:
University Children's Hospital, Zurich
Conditions:
Need for Tracheal Tube Exchange
Presence of Post-extubation Laryngeal Oedema
Eligibility:
All Genders
1-5 years
Phase:
NA
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) comparin...
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....
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT00221377
Start Date
April 1 2005
End Date
June 1 2007
Last Update
May 17 2012
Active Locations (24)
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1
Anesthesia And Critical Care Medicine - Medical University
Innsbruck, Austria
2
Departement of Anaesthesia - Cliniques Universitaire St. Luc
Brussels, Belgium
3
Dept. of Anaesthesia and Reanimation - University Hospital Motol
Prague, Czechia
4
Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg
Augsburg, Germany