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"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

NCT00221377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2012-05-17

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Intubation using tracheal tubes with or without cuff

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Markus Weiss, Prof MD · University Children's Hospital, Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Slovakia
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221377 on ClinicalTrials.gov