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"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

September 13, 2005
May 16, 2012
April 2005
June 2007   (final data collection date for primary outcome measure)
post-extubation stridor (airway stenosis)
Same as current
Complete list of historical versions of study NCT00221377 on ClinicalTrials.gov Archive Site
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"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
"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.

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%.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Need for Tracheal Tube Exchange
  • Presence of Post-extubation Laryngeal Oedema
Device: Intubation using tracheal tubes with or without cuff
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4000
June 2007
June 2007   (final data collection date for primary outcome measure)

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%
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   Germany,   Slovakia,   Sweden,   Switzerland,   United Kingdom
 
NCT00221377
STV1/05, no grants
Not Provided
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Markus Weiss, Prof MD University Children's Hospital, Anesthesiology
University Children's Hospital, Zurich
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP