"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

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.

Study Overview

• Status: Completed
• Conditions: Need for Tracheal Tube Exchange; Presence of Post-extubation Laryngeal Oedema
• Intervention / Treatment: Device: Intubation using tracheal tubes with or without cuff

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 4000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Anesthesia And Critical Care Medicine - Medical University
• Belgium
  • Brussels, Belgium
    • Departement of Anaesthesia - Cliniques Universitaire St. Luc
• Czech Republic
  • Prague, Czech Republic
    • Dept. of Anaesthesia and Reanimation - University Hospital Motol
• Germany
  • Augsburg, Germany
    • Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg
  • Berlin, Germany
    • Clinic of Anesthesiology - Charite-Universitätsmedizin
  • Berlin, Germany
    • Dep. Anesthesiology and Intensive Care - Helios Klinikum Berlin-Buch
  • Hannover, Germany, 30173
    • Dept. of Anaesthesia - Kinderkrankenhaus auf der Bult
  • Loerrach, Germany, 78539
    • Dept. of Anaesthesia Kliniken Loerrach
  • Mannheim, Germany
    • Anaesthesia and Intensive Care - University Hospital Mannheim
  • München, Germany
    • Klinik für Anaesthesie, LMU München - Dr. U. Haunersches Kinderspital
  • Regensburg, Germany
    • Anaesthesia - Klinik St. Hedwig
• Slovakia
  • Bratislava, Slovakia
    • Children's University Hospital - Dept. of Anaesthesia and Intensive Care
  • Kosice, Slovakia, 04011
    • Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur
• Sweden
  • Stockholm, Sweden
    • Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital
• Switzerland
  • Aarau, Switzerland
    • Klinik für Anästhesie und Op. Intensivmedizin
  • Bern, Switzerland
    • Klinik für Anästhesiologie - Inselspital
  • Geneva, Switzerland, 1205
    • Dept. of Anaesthesia, Geneva Children's Hospital
  • Lausanne, Switzerland
    • Service d'Anesthesiologie - CHUV
  • St. Gallen, Switzerland
    • Anästhesie - Ostschweizer Kinderspital
  • ZH
    • Zurich, ZH, Switzerland, 8032
      • University Children's Hospital
• United Kingdom
  • Aberdeen, United Kingdom
    • Anaesthetics - Royal Aberdeen Children's Hospital
  • Glasgow, United Kingdom
    • Anaesthetic Department - Royal Hospital for Sick Children
  • Leeds, United Kingdom
    • Anaesthetic Department - Ledds General Infirmary
  • London, United Kingdom
    • Anaesthesia - Chelsa and Westminster NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
post-extubation stridor (airway stenosis)

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Markus Weiss, Prof MD, University Children's Hospital, Anesthesiology

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 17, 2012
• Last Update Submitted That Met QC Criteria: May 16, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: children; intubation; cuff; tube; trachea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngeal Edema
• Other Study ID Numbers: STV1/05; no grants