"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"

NCT ID: NCT00221377

Last Updated: 2012-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-06-30

Brief 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.

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%.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Intubation using tracheal tubes with or without cuff

Intervention Type: DEVICE

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%

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Weiss, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Anesthesiology

Locations

Anesthesia And Critical Care Medicine - Medical University

Innsbruck, , Austria

Departement of Anaesthesia - Cliniques Universitaire St. Luc

Brussels, , Belgium

Dept. of Anaesthesia and Reanimation - University Hospital Motol

Prague, , Czechia

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

Hanover, , Germany

Dept. of Anaesthesia Kliniken Loerrach

Loerrach, , Germany

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

Children's University Hospital - Dept. of Anaesthesia and Intensive Care

Bratislava, , Slovakia

Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur

Košice, , Slovakia

Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital

Stockholm, , Sweden

University Children's Hospital

Zurich, Canton of Zurich, Switzerland

Klinik für Anästhesie und Op. Intensivmedizin

Aarau, , Switzerland

Klinik für Anästhesiologie - Inselspital

Bern, , Switzerland

Dept. of Anaesthesia, Geneva Children's Hospital

Geneva, , Switzerland

Service d'Anesthesiologie - CHUV

Lausanne, , Switzerland

Anästhesie - Ostschweizer Kinderspital

Sankt Gallen, , Switzerland

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

Countries

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

Other Identifiers

STV1/05

Identifier Type: -

Identifier Source: org_study_id

no grants

Identifier Type: -

Identifier Source: secondary_id