Clinical trial NCT00221377: "Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
Official title: "Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Need for Tracheal Tube Exchange
Presence of Post-extubation Laryngeal Oedema
Keywords: intubation
trachea
tube
cuff
children
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 4000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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%

Primary outcomes:
measure: post-extubation stridor (airway stenosis)
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Anesthesia And Critical Care Medicine - Medical University
city: Brussels
country: Belgium
facility: Departement of Anaesthesia - Cliniques Universitaire St. Luc
city: Prague
country: Czech Republic
facility: Dept. of Anaesthesia and Reanimation - University Hospital Motol
city: Augsburg
country: Germany
facility: Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg
city: Berlin
country: Germany
facility: Clinic of Anesthesiology - Charite-Universitätsmedizin
city: Berlin
country: Germany
facility: Dep. Anesthesiology and Intensive Care - Helios Klinikum Berlin-Buch
city: Hannover
country: Germany
facility: Dept. of Anaesthesia - Kinderkrankenhaus auf der Bult
city: Loerrach
country: Germany
facility: Dept. of Anaesthesia Kliniken Loerrach
city: Mannheim
country: Germany
facility: Anaesthesia and Intensive Care - University Hospital Mannheim
city: München
country: Germany
facility: Klinik für Anaesthesie, LMU München - Dr. U. Haunersches Kinderspital
city: Regensburg
country: Germany
facility: Anaesthesia - Klinik St. Hedwig
city: Bratislava
country: Slovakia
facility: Children's University Hospital - Dept. of Anaesthesia and Intensive Care
city: Kosice
country: Slovakia
facility: Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur
city: Stockholm
country: Sweden
facility: Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital
city: Zurich
country: Switzerland
facility: University Children's Hospital
state: ZH
city: Aarau
country: Switzerland
facility: Klinik für Anästhesie und Op. Intensivmedizin
city: Bern
country: Switzerland
facility: Klinik für Anästhesiologie - Inselspital
city: Geneva
country: Switzerland
facility: Dept. of Anaesthesia, Geneva Children's Hospital
city: Lausanne
country: Switzerland
facility: Service d'Anesthesiologie - CHUV
city: St. Gallen
country: Switzerland
facility: Anästhesie - Ostschweizer Kinderspital
city: Aberdeen
country: United Kingdom
facility: Anaesthetics - Royal Aberdeen Children's Hospital
city: Glasgow
country: United Kingdom
facility: Anaesthetic Department - Royal Hospital for Sick Children
city: Leeds
country: United Kingdom
facility: Anaesthetic Department - Ledds General Infirmary
city: London
country: United Kingdom
facility: Anaesthesia - Chelsa and Westminster NHS Trust
Study officials:
affiliation: University Children's Hospital, Anesthesiology
name: Markus Weiss, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: