IntubationNCT02350933
Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation
A study testing Endoscopy in people with Intubation and Endoscopy, run by University Children's Hospital, Zurich at 5 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether possible damages of the trachea caused by a prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if cuffed tracheal tubes cause less damages than cuffed tubes. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Intubation, Endoscopy
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Sep 2011to Dec 2017
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Planned elective intervention/surgery/diagnostics/endoscopy and general anaesthesia with airway instrumentation involving muscle paralysis in children, aged 1 month (UK) or from birth (other centers) to 16 years having prior prolonged (≥ 24h) tracheal intubation (s) during ICU-stay (s) within the study centre (patients for diagnosis/treatment of stridor are also included (see exclusion criteria also below)).
- No known risk for regurgitation
- Written parental consent
- American Society of Anesthesiologists (ASA) physical status < IV
Who cannot join
- No parental written consent
- Known airway anomalies associated with syndromes
- Known or suspected difficult intubation
- Emergency surgery or intervention
- Full stomach and/or at risk for regurgitation
- ASA physical status IV and higher
Show all 9Show fewer
- Patients with current or prior tracheostomy
- Known, suspected or potential cervical spine pathology (e.g. Down's Syndrome)
- Insufficient clinical details from previous prolonged intubation
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Kinderkrankenhaus Amsterdamer Straße
Cologne, North Rhine-Westphalia, 50735
Asklepios Kinderklinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, 53757
Netherlands1 site
Erasmus Medical Center, Sophia Children's Hospital
Rotterdam, 3015
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
About this study
The purpose of this study is to determine whether possible damages of the trachea caused by a prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if cuffed tracheal tubes cause less damages than cuffed tubes.
Read the detailed description
The aim of the study is to systematically evaluate airway injury by rigid endoscopy in children (1 month to 16 years of age) with previous prolonged (> 24h) tracheal intubation with a special focus on whether their trachea was intubated with a cuffed or an uncuffed tracheal tube.
After induction of anaesthesia and obtaining venous access, neuromuscular blocking agents are administered and facemask pre-oxygenation occurs for 2 minutes. Direct laryngoscopy is then performed in the preoxygenated, paralysed and conventionally monitored patient to obtain a direct vision. Then a rigid endoscope with endoscopy camera is carefully guided through the larynx down to the carina and drawn back under monitor vision with electronic recording.
An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.
Beside tracheal tube type, factors such as intubator, sedation management, age, length of intubation, nasal or oral intubation and time point of endoscopy will affect presence, absence or incidence of potential airway injuries caused by prolonged tracheal intubation. Thus it is difficult to perform a power calculation to figure out number of patients to demonstrate or exclude a statistically significant difference between tube types. Using the incidence of subglottic stenosis, as the worst case scenario outcome after longterm intubation, an incidence of less than 2 % seems to be reasonable in uncuffed tracheal tubes.So the primary hypothesis to be tested is equivalence in major complication rates defined as subglottic stenosis comparing cuffed versus uncuffed tracheal tubes.
Specifically, the primary hypothesis relates to the main outcome criteria of this study, which is subglottic stenosis after longterm intubation. The null-hypothesis Ho is defined as no difference in the incidence rates of subglottic stenosis between cuffed and uncuffed groups. The null-hypothesis (Ho: μ-Diff = 0) will be compared with the alternative hypothesis (H1: μ-Diff <> 0). The study is designed to detect a clinically unacceptable deterioration of 4% above the baseline airway-injury rate of 2% when using uncuffed tubes with a power of 80% and a type I error probability of less than 5%. Sample sizes of 376 from the cuffed group and 376 from the uncuffed group achieve 80% power at a 5% significance level using a one-sided equivalence test of proportions when the proportion in the standard group (uncuffed TT) is 0.02 and the proportion in the experimental group (cuffed TT) being tested for equivalence is 0.02 and the maximum allowable increase between these proportions that still results in equivalence (the range of equivalence) is 0.04. In total 1000 patients with prior long-term intubation (> 24 hours) using a cuffed (500) or an uncuffed (500) tracheal tube will be recruited / included from different study centres.
- Conditions
- Intubation, Endoscopy
- Being tested
- Endoscopy
- Keywords
- tracheal damages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
A rigid endoscopy of the larynx and the trachea until the carina is performed using a rigid 0° endoscope.
| Study group | Role | What they receive |
|---|---|---|
| 0° rigid endoscope | Other | Endoscopy of the trachea is performed using a 0° rigid endoscope Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with evidence of subglottic stenosis after longterm intubation with cuffed versus uncuffed tracheal tubes
An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.
Measured: After an average induction period of 10 min of an anesthesia with a planned intubation after the endoscopy
Secondary outcomes (10)
Numbers of prior intubations
Numbers of shortterm and prolonged (>24h) and numbers of intubations with cuffed and uncuffed tubes are listed
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Duration of prior longterm intubation
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Reason for prior longterm intubation
Reason for prior longterm intubation is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Route of prior longterm intubation
Route of prior longterm intubation (nasal or oral) is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Tube type used for prior longterm intubation
Tube type used for prior longterm intubation (cuffed or uncuffed) is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Tube brand used for prior longterm intubation
Tube brand used for prior longterm intubation is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Tube size used for prior longterm intubation
Tube size (inner diameter) used for prior longterm intubation is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Site of prior longterm intubation
Site of prior longterm intubation is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Maximal cuff pressure during prior longterm intubation
Maximal cuff pressure in cmH2O during longterm intubation is look up in patient's medical records.
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Number of patients with a stridor event after extubation of prior longterm intubation
Measured: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startSep 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Asklepios-Klinik Sankt Augustin, Kinderkrankenhaus Amsterdamer Straße, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Markus Weiss, Prof., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350933
- Sponsor's protocol ID
- Endostudy
- Status last verified
- May 2018
- First submitted
- 12 Dec 2014
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation
- ClinicalTrials.gov ID
- NCT02350933
- Acronym / sponsor ID
- Endostudy
- Conditions
- Intubation, Endoscopy
- Keywords
- tracheal damages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Asklepios-Klinik Sankt Augustin, Kinderkrankenhaus Amsterdamer Straße, Erasmus Medical Center
- Study start
- Sep 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Jan 2015 (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.
The purpose of this study is to determine whether possible damages of the trachea caused by a prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if cuffed tracheal tubes cause less damages than cuffed tubes.
Detailed description
The aim of the study is to systematically evaluate airway injury by rigid endoscopy in children (1 month to 16 years of age) with previous prolonged (> 24h) tracheal intubation with a special focus on whether their trachea was intubated with a cuffed or an uncuffed tracheal tube.
After induction of anaesthesia and obtaining venous access, neuromuscular blocking agents are administered and facemask pre-oxygenation occurs for 2 minutes. Direct laryngoscopy is then performed in the preoxygenated, paralysed and conventionally monitored patient to obtain a direct vision. Then a rigid endoscope with endoscopy camera is carefully guided through the larynx down to the carina and drawn back under monitor vision with electronic recording.
An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.
Beside tracheal tube type, factors such as intubator, sedation management, age, length of intubation, nasal or oral intubation and time point of endoscopy will affect presence, absence or incidence of potential airway injuries caused by prolonged tracheal intubation. Thus it is difficult to perform a power calculation to figure out number of patients to demonstrate or exclude a statistically significant difference between tube types. Using the incidence of subglottic stenosis, as the worst case scenario outcome after longterm intubation, an incidence of less than 2 % seems to be reasonable in uncuffed tracheal tubes.So the primary hypothesis to be tested is equivalence in major complication rates defined as subglottic stenosis comparing cuffed versus uncuffed tracheal tubes.
Specifically, the primary hypothesis relates to the main outcome criteria of this study, which is subglottic stenosis after longterm intubation. The null-hypothesis Ho is defined as no difference in the incidence rates of subglottic stenosis between cuffed and uncuffed groups. The null-hypothesis (Ho: μ-Diff = 0) will be compared with the alternative hypothesis (H1: μ-Diff <> 0). The study is designed to detect a clinically unacceptable deterioration of 4% above the baseline airway-injury rate of 2% when using uncuffed tubes with a power of 80% and a type I error probability of less than 5%. Sample sizes of 376 from the cuffed group and 376 from the uncuffed group achieve 80% power at a 5% significance level using a one-sided equivalence test of proportions when the proportion in the standard group (uncuffed TT) is 0.02 and the proportion in the experimental group (cuffed TT) being tested for equivalence is 0.02 and the maximum allowable increase between these proportions that still results in equivalence (the range of equivalence) is 0.04. In total 1000 patients with prior long-term intubation (> 24 hours) using a cuffed (500) or an uncuffed (500) tracheal tube will be recruited / included from different study centres.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0° rigid endoscope | Other | Procedure: EndoscopyEndoscopy of the trachea is performed using a 0° rigid endoscope |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Planned elective intervention/surgery/diagnostics/endoscopy and general anaesthesia with airway instrumentation involving muscle paralysis in children, aged 1 month (UK) or from birth (other centers) to 16 years having prior prolonged (≥ 24h) tracheal intubation (s) during ICU-stay (s) within the study centre (patients for diagnosis/treatment of stridor are also included (see exclusion criteria also below)).
- No known risk for regurgitation
- Written parental consent
- American Society of Anesthesiologists (ASA) physical status < IV
Key exclusion criteria (9 listed)
- No parental written consent
- Known airway anomalies associated with syndromes
- Known or suspected difficult intubation
- Emergency surgery or intervention
- 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 |
|---|---|---|
| EndoscopyA rigid endoscopy of the larynx and the trachea until the carina is performed using a rigid 0° endoscope. | Procedure or surgery | 0° rigid endoscope |
Primary outcome
Number of patients with evidence of subglottic stenosis after longterm intubation with cuffed versus uncuffed tracheal tubes
Time frame: After an average induction period of 10 min of an anesthesia with a planned intubation after the endoscopy
An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.
10 secondary outcomes
Numbers of prior intubations
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Duration of prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Reason for prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Route of prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Tube type used for prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Tube brand used for prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Tube size used for prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Site of prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Maximal cuff pressure during prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
Number of patients with a stridor event after extubation of prior longterm intubation
Time frame: Retrospective data analysis of former intubations is performed within two years after the endoscopy
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 9 May 2018.
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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. principal investigator
University Children's Hospital, Zurich
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Intubation and Endoscopy, run by University Children's Hospital, Zurich at 5 sites in 4 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 4 inclusion and 9 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands, Switzerland, United Kingdom. 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?
Number of patients with evidence of subglottic stenosis after longterm intubation with cuffed versus uncuffed tracheal tubes (time frame: After an average induction period of 10 min of an anesthesia with a planned intubation after the endoscopy). 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 9 May 2018.