"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

Need for Tracheal Tube Exchange Clinical Trial

Official title:

"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221377
• Other study ID #: STV1/05
• Secondary ID: no grants
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 16, 2012
• Start date: April 2005
• Est. completion date: June 2007

Study information

• Verified date: December 2011
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Kantonale Ethikkomission Zurich
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngeal Edema
• Need for Tracheal Tube Exchange
• Presence of Post-extubation Laryngeal Oedema

Intervention

Device:
• Intubation using tracheal tubes with or without cuff

Locations

Country	Name	City	State
Austria	Anesthesia And Critical Care Medicine - Medical University	Innsbruck
Belgium	Departement of Anaesthesia - Cliniques Universitaire St. Luc	Brussels
Czech Republic	Dept. of Anaesthesia and Reanimation - University Hospital Motol	Prague
Germany	Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg	Augsburg
Germany	Clinic of Anesthesiology - Charite-Universitätsmedizin	Berlin
Germany	Dep. Anesthesiology and Intensive Care - Helios Klinikum Berlin-Buch	Berlin
Germany	Dept. of Anaesthesia - Kinderkrankenhaus auf der Bult	Hannover
Germany	Dept. of Anaesthesia Kliniken Loerrach	Loerrach
Germany	Anaesthesia and Intensive Care - University Hospital Mannheim	Mannheim
Germany	Klinik für Anaesthesie, LMU München - Dr. U. Haunersches Kinderspital	München
Germany	Anaesthesia - Klinik St. Hedwig	Regensburg
Slovakia	Children's University Hospital - Dept. of Anaesthesia and Intensive Care	Bratislava
Slovakia	Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur	Kosice
Sweden	Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital	Stockholm
Switzerland	Klinik für Anästhesie und Op. Intensivmedizin	Aarau
Switzerland	Klinik für Anästhesiologie - Inselspital	Bern
Switzerland	Dept. of Anaesthesia, Geneva Children's Hospital	Geneva
Switzerland	Service d'Anesthesiologie - CHUV	Lausanne
Switzerland	Anästhesie - Ostschweizer Kinderspital	St. Gallen
Switzerland	University Children's Hospital	Zurich	ZH
United Kingdom	Anaesthetics - Royal Aberdeen Children's Hospital	Aberdeen
United Kingdom	Anaesthetic Department - Royal Hospital for Sick Children	Glasgow
United Kingdom	Anaesthetic Department - Ledds General Infirmary	Leeds
United Kingdom	Anaesthesia - Chelsa and Westminster NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Germany,  Slovakia,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-extubation stridor (airway stenosis)