"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT00221377
First received: September 13, 2005
Last updated: May 16, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention
Need for Tracheal Tube Exchange
Presence of Post-extubation Laryngeal Oedema
Device: Intubation using tracheal tubes with or without cuff

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: "Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • post-extubation stridor (airway stenosis)

Estimated Enrollment: 4000
Study Start Date: April 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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%.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221377

Locations
Austria
Anesthesia And Critical Care Medicine - Medical University
Innsbruck, Austria
Belgium
Departement of Anaesthesia - Cliniques Universitaire St. Luc
Brussels, Belgium
Czech Republic
Dept. of Anaesthesia and Reanimation - University Hospital Motol
Prague, Czech Republic
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, 30173
Dept. of Anaesthesia Kliniken Loerrach
Loerrach, Germany, 78539
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, Germany
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, Slovakia, 04011
Sweden
Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital
Stockholm, Sweden
Switzerland
University Children's Hospital
Zurich, ZH, Switzerland, 8032
Klinik für Anästhesie und Op. Intensivmedizin
Aarau, Switzerland
Klinik für Anästhesiologie - Inselspital
Bern, Switzerland
Dept. of Anaesthesia, Geneva Children's Hospital
Geneva, Switzerland, 1205
Service d'Anesthesiologie - CHUV
Lausanne, Switzerland
Anästhesie - Ostschweizer Kinderspital
St. Gallen, Switzerland
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, United Kingdom
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Markus Weiss, Prof MD University Children's Hospital, Anesthesiology
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT00221377     History of Changes
Other Study ID Numbers: STV1/05, no grants
Study First Received: September 13, 2005
Last Updated: May 16, 2012
Health Authority: Switzerland: Kantonale Ethikkomission Zurich

Keywords provided by University Children's Hospital, Zurich:
intubation
trachea
tube
cuff
children

Additional relevant MeSH terms:
Laryngeal Edema
Laryngeal Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014