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Search / Trial NCT00221377

"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

Launched by UNIVERSITY CHILDREN'S HOSPITAL, ZURICH · Sep 13, 2005

Trial Information

Current as of May 15, 2025

Completed

Keywords

Intubation Trachea Tube Cuff Children

ClinConnect Summary

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, performe...

Gender

ALL

Eligibility 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%

About University Children's Hospital, Zurich

The University Children's Hospital Zurich is a leading academic medical institution dedicated to advancing pediatric healthcare through innovative research and clinical excellence. Affiliated with the University of Zurich, the hospital specializes in a wide range of pediatric disciplines, offering comprehensive care to children and adolescents. As a prominent sponsor of clinical trials, the institution is committed to exploring new therapies and improving treatment protocols, ensuring that young patients benefit from the latest advancements in medicine. With a focus on collaboration, the hospital engages in partnerships with researchers, healthcare professionals, and pharmaceutical companies to drive impactful studies that enhance the health and well-being of children globally.

Locations

Innsbruck, , Austria

Brussels, , Belgium

Prague, , Czech Republic

Augsburg, , Germany

Berlin, , Germany

Berlin, , Germany

Hannover, , Germany

Loerrach, , Germany

Mannheim, , Germany

München, , Germany

Regensburg, , Germany

Bratislava, , Slovakia

Kosice, , Slovakia

Stockholm, , Sweden

Zurich, Zh, Switzerland

Aarau, , Switzerland

Bern, , Switzerland

Geneva, , Switzerland

Lausanne, , Switzerland

St. Gallen, , Switzerland

Aberdeen, , United Kingdom

Glasgow, , United Kingdom

Leeds, , United Kingdom

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Markus Weiss, Prof MD

Principal Investigator

University Children's Hospital, Anesthesiology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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