“Cuffed Versus Uncuffed Tracheal Tubes in Small Children” - Full Text View

Sponsored by:	University Children's Hospital, Zurich
Information provided by:	University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:	NCT00221377

Purpose

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.

Condition	Intervention
1) Need for Tracheal Tube Exchange 2) Presence of Post-Extubation Laryngeal Oedema	Device: Intubation using tracheal tubes with or without cuff

MedlinePlus related topics: Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	“Cuffed Versus Uncuffed Tracheal Tubes in Small Children”

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:

post-extubation stridor (airway stenosis)

Estimated Enrollment:	4000
Study Start Date:	April 2005
Estimated Study Completion Date:	June 2006

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

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221377

Contacts

Contact: Markus Weiss, MD	+41 44 266 73 65	markus.weiss@kispi.unizh.ch
Contact: Christian Keller, MD, MS	++43 512 504 80357	Christian.Keller@uibk.ac.at

Locations

Austria
Anesthesia And Critical Care Medicine - Medical University	Recruiting
Innsbruck, Austria
Contact: Stephan Eschertzhuber, MD
Principal Investigator: Stephan Eschertzhuber, MD
Sub-Investigator: Winfried Roth, MD
Belgium
Departement of Anaesthesia - Cliniques Universitaire St. Luc	Recruiting
Brussels, Belgium
Contact: Thierry Pirotte, MD
Principal Investigator: Thierry Pirotte, MD
Sub-Investigator: Francis Veyckemans, MD
Czech Republic
Dept. of Anaesthesia and Reanimation - University Hospital Motol	Recruiting
Prague, Czech Republic
Contact: Vladimir Mixa, MD
Principal Investigator: Vladimir Mixa, MD
Sub-Investigator: Gabriel Otakar, MD
Germany
Anaesthesia and Intensive Care - University Hospital Mannheim	Recruiting
Mannheim, Germany
Contact: Hann-Jürgen Rapp, MD
Principal Investigator: Hans-Jürgen Rapp, MD
Sub-Investigator: Elke Thiel, MD
Dept. of Anaesthesia and Intensive Care Olgaspital	Recruiting
Stuttgart, Germany, 70176
Contact: Sabine Haag, MD
Principal Investigator: Sabine Haag, MD
Sub-Investigator: Joachim Stelzner, MD
Dept. of Anaesthesia - Kinderkrankenhaus auf der Bult	Recruiting
Hannover, Germany, 30173
Contact: Karin Boos, MD
Principal Investigator: Karin Boos, MD
Sub-Investigator: Stefan Krohn, MD
Dept. of Anaesthesia Kliniken Loerrach	Recruiting
Loerrach, Germany, 78539
Contact: Walter Heindl, MD, PhD
Principal Investigator: Walter Heindl, MD, PhD
Sub-Investigator: Harald Schepperle, MD
Clinic of Anesthesiology - Charite-Universitätsmedizin	Recruiting
Berlin, Germany
Contact: Andreas Machotta, MD
Principal Investigator: Andreas Machotta, MD
Sub-Investigator: Claudia Hoehne, MD
Anaesthesia - Klinik St. Hedwig	Recruiting
Regensburg, Germany
Contact: Harals Hollnberger, MD
Principal Investigator: Harald Holluberger, MD
Sub-Investigator: Berhard Frank, MD
Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg	Recruiting
Augsburg, Germany
Contact: Helmuth Forst, MD
Principal Investigator: Helmuth Forst, MD
Principal Investigator: Helmuth Forst, MD
Sub-Investigator: Dietmar Crass, MD
Klinik für Anaesthesie, LMU München - Dr. U. Haunersches Kinderspital	Recruiting
München, Germany
Contact: Gerhard Kuhnle, MD, PD
Principal Investigator: Gerhard Kunhle, MD, PD
Sub-Investigator: Tanja Hütte, MD
Dep. Anesthesiology and Intensive Care - Helios Klinikum Berlin-Buch	Recruiting
Berlin, Germany
Contact: Jochen Strauss, MD, Prof.
Principal Investigator: Jochen Strauss, MD, Prof.
Sub-Investigator: Klaus Bunke, MD
Ireland
Anaesthesia and Intensive Care - Royal Belfast Hospital for Sick Children	Recruiting
Belfast, Ireland
Contact: Paul Loan, MD
Principal Investigator: Paul Loan, MD
Sub-Investigator: Peter Crean, MD
Netherlands
Afdeling Anesthesiologie	Recruiting
Groningen, Netherlands
Contact: Rob Steur, MD
Principal Investigator: Rob Steur, MD
Slovakia
Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur	Recruiting
Kosice, Slovakia, 04011
Contact: Monika Grochova, MD, PhD
Principal Investigator: Monika Grochova, MD, PhD
Sub-Investigator: Lubica Skripecka, MD
Children's University Hospital - Dept. of Anaesthesia and Intensive Care	Recruiting
Bratislava, Slovakia
Contact: Daniel Csomor, MD
Principal Investigator: Daniel Csomor, MD
Sub-Investigator: Bransilav Podhoransky, MD
Sweden
Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital	Recruiting
Stockholm, Sweden
Contact: Mickael Rolfs, MD
Principal Investigator: Mickael Rolfs, MD
Sub-Investigator: Boel Wiktors, CRNA
Sub-Investigator: Per-Arne Lonnqvist, MD
Switzerland
Dept. of Anaesthesia, Geneva Children's Hospital	Recruiting
Geneva, Switzerland, 1205
Contact: Walid Habre, MD
Principal Investigator: Walid Habre, MD, PhD
Sub-Investigator: Michel Pellegrini, MD
Klinik für Anästhesiologie - Inselspital	Recruiting
Bern, Switzerland
Contact: Robert Greif, MD, PD
Sub-Investigator: Frankziska Stucki, MD
Principal Investigator: Robert Greif, MD, PD
Sub-Investigator: Seiler Stefan, MD
Anästhesie - Ostschweizer Kinderspital	Recruiting
St. Gallen, Switzerland
Contact: Markus Oberhauser, MD
Principal Investigator: Markus Oberhauser, MD
Service d'Anesthesiologie - CHUV	Recruiting
Lausanne, Switzerland
Contact: Marc-Andre Bernath, MD
Principal Investigator: Marc-Andre Bernath, MD
Sub-Investigator: Mirko Dolci, MD
Klinik für Anästhesie und Op. Intensivmedizin	Recruiting
Aarau, Switzerland
Contact: Bruno Hartmann, MD
Principal Investigator: Bruno Hartmann, MD
Sub-Investigator: Otto Hilfiker, MD, PD
Switzerland, ZH
University Children's Hospital	Recruiting
Zurich, ZH, Switzerland, 8032
Contact: Joachim Fischer, MD, MS +41 44 266 7917 joachim.fischer@kispi.unizh.ch
Principal Investigator: Markus Weiss, MD
Principal Investigator: Andreas Gerber, MD
Sub-Investigator: Bettina Salgo, MD
Sub-Investigator: Achim Schmitz, MD
Sub-Investigator: George Henze, MD
United Kingdom
Anaesthetics - Royal Aberdeen Children's Hospital	Recruiting
Aberdeen, United Kingdom
Contact: Mark Bloch, MD
Principal Investigator: Mark Bloch, MD
Sub-Investigator: Graham Wilson, MD
Anaesthetic Department - Ledds General Infirmary	Recruiting
Leeds, United Kingdom
Contact: Stephanie Bew, MD
Principal Investigator: Stephanie Bew, MD
Sub-Investigator: Moira O'Mrova, MD
Anaesthetic Department - Royal Hospital for Sick Children	Recruiting
Glasgow, United Kingdom
Contact: Philip Bolton, MD
Principal Investigator: Philip Bolton, MD
Sub-Investigator: Neil Morton, MD
Anaesthesia - Chelsa and Westminster NHS Trust	Recruiting
London, United Kingdom
Contact: Peter Brooks, MD
Principal Investigator: Peter Brooks, MD
Sub-Investigator: Manisha Kulkarni, MD
Anaesthesia - Royal Manchester Children's Hospital	Recruiting
Manchester, United Kingdom
Contact: George Meakin, MD
Principal Investigator: George Meakin, MD
Sub-Investigator: Dav Patel, MD

Sponsors and Collaborators

University Children's Hospital, Zurich

Investigators

Principal Investigator:

Markus Weiss, MD

Department of Anaesthesia, University Children's Hospital, Zurich, Switzerland

Study ID Numbers:	STV1/05, no grants
Study First Received:	September 13, 2005
Last Updated:	September 25, 2005
ClinicalTrials.gov Identifier:	NCT00221377
Health Authority:	Switzerland: Kantonale Ethikkomission Zurich