Need for Tracheal Tube ExchangeNCT00221377
"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
A study testing Intubation using tracheal tubes with or without cuff in people with Need for Tracheal Tube Exchange and Presence of Post-extubation Laryngeal Oedema, run by University Children's Hospital, Zurich at 24 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Need for Tracheal Tube Exchange, Presence of Post-extubation Laryngeal Oedema
- What is being tested?
- Intubation using tracheal tubes with or without cuff
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 24 sitesin 8 countries
- Study dates
- Apr 2005to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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%
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
Germany8 sites
Klinik für Anasthesiologie und Operative Intensivmedizin - Klinikum Augsburg
Augsburg
Clinic of Anesthesiology - Charite-Universitätsmedizin
Berlin
Dep. Anesthesiology and Intensive Care - Helios Klinikum Berlin-Buch
Berlin
Dept. of Anaesthesia - Kinderkrankenhaus auf der Bult
Hanover, 30173
Dept. of Anaesthesia Kliniken Loerrach
Loerrach, 78539
Anaesthesia and Intensive Care - University Hospital Mannheim
Mannheim
Klinik für Anaesthesie, LMU München - Dr. U. Haunersches Kinderspital
München
Anaesthesia - Klinik St. Hedwig
Regensburg
Switzerland6 sites
Klinik für Anästhesie und Op. Intensivmedizin
Aarau
Klinik für Anästhesiologie - Inselspital
Bern
Dept. of Anaesthesia, Geneva Children's Hospital
Geneva, 1205
Service d'Anesthesiologie - CHUV
Lausanne
Anästhesie - Ostschweizer Kinderspital
Sankt Gallen
University Children's Hospital
Zurich, Canton of Zurich, 8032
United Kingdom4 sites
Anaesthetics - Royal Aberdeen Children's Hospital
Aberdeen
Anaesthetic Department - Royal Hospital for Sick Children
Glasgow
Anaesthetic Department - Ledds General Infirmary
Leeds
Anaesthesia - Chelsa and Westminster NHS Trust
London
Slovakia2 sites
Children's University Hospital - Dept. of Anaesthesia and Intensive Care
Bratislava
Dept. of Anaesthesia and Intensive Care - Faculty Hospital of Luis Pasteur
Košice, 04011
Austria1 site
Anesthesia And Critical Care Medicine - Medical University
Innsbruck
Belgium1 site
Departement of Anaesthesia - Cliniques Universitaire St. Luc
Brussels
Czechia1 site
Dept. of Anaesthesia and Reanimation - University Hospital Motol
Prague
Sweden1 site
Dept. of Anaesthesia and Intensive Care - Astrid Lindgrens Children's Hospital
Stockholm
About this study
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.
Read the 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%.
- Being tested
- Intubation using tracheal tubes with or without cuff
- Keywords
- intubation, trachea, tube, cuff, children
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation using tracheal tubes with or without cuffDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
post-extubation stridor (airway stenosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Need for Tracheal Tube ExchangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Weiss, Prof MD, Principal investigator, University Children's Hospital, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221377
- Sponsor's protocol ID
- STV1/05
- Other IDs
- no grants
- Status last verified
- Dec 2011
- First submitted
- 13 Sep 2005
- Last updated
- 17 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
- ClinicalTrials.gov ID
- NCT00221377
- Acronym / sponsor ID
- STV1/05
- Keywords
- intubation, trachea, tube, cuff, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intubation using tracheal tubes with or without cuff | Device | – |
Primary outcome
post-extubation stridor (airway stenosis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Weiss, Prof MD principal investigator
University Children's Hospital, Anesthesiology
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation using tracheal tubes with or without cuff in people with Need for Tracheal Tube Exchange and Presence of Post-extubation Laryngeal Oedema, run by University Children's Hospital, Zurich at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Switzerland, United Kingdom, Slovakia, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-extubation stridor (airway stenosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.