Tracheal Intubation MorbidityNCT01215422
Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes
An observational study of Tracheal Intubation Morbidity, run by University of Alberta at 1 site in Canada.
Trial summary
There are two new instruments on the market that anesthesiologists use when putting a breathing tube into the lungs of patients. The purpose of this study is to see how easily anesthesiologists can learn to use them in children. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Tracheal Intubation Morbidity
- What is being tested?
- timed intubation
- Type of treatment
- Surgery or procedure
- How many people
- 646 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Jul 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children being intubated for surgery
Who may be able to join
- Children requiring intubation for elective or non-elective surgery
- Anesthesiologists who care for children at Stollery Children's Hospital
Who cannot join
- Children with raised intracranial pressure
- Children with potential cervical spine injuries
- Children at risk for regurgitation because of a full stomach
- Children who were anticipated to have a difficult airway based on their physical appearance or previous experience were excluded.
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesiologists Learning to Use Videolaryngoscopes in Children
There are two new instruments on the market that anesthesiologists use when putting a breathing tube into the lungs of patients. The purpose of this study is to see how easily anesthesiologists can learn to use them in children.
Read the detailed description
Each anesthesiologist performed 20 timed baseline intubations. They were then randomized to perform 20 timed intubations with one of the two new videolaryngoscopes followed by 20 with the other new videolaryngoscope. The goal was to see how quickly they could become proficient.
- Conditions
- Tracheal Intubation Morbidity
- Being tested
- timed intubation
- Keywords
- Surgical procedures, Intubation, Anesthesiologist, Laryngoscope, Videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timed intubationProcedure or surgery
timed intubation
| Study group | Role | What they receive |
|---|---|---|
| children intubated with Glidescope | children intubated with Glidescope Receives: Procedure: timed intubation | |
| children intubated with DCI | children intubated with DCI Receives: Procedure: timed intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in Learning to Use a Videolaryngoscope(VLS)
Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. "Rapid Success" was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . "Delayed Success" was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having "No Success".
Measured: Up to 5 minutes per intubation
Secondary outcomes (5)
Cormack & Lehane Score
This Outcome was designed to determine if the view of the airway as determined by the Cormack \& Lehane grading system is improved by use of the GlideScope (GS) video laryngoscope and/or the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope as this would be a surrogate marker for utility in a difficult airway. Score is reported as a whole number from I to IV with I being an easy intubation and IV being one where the larynx cannot be visualized at all.
Measured: reported during intubation (up to 5 minutes)
Time to Intubation, Analyzed by Order of Laryngoscopes Used
To determine if the learning curve was altered by the order in which the two new laryngoscopes were learned by the anesthesiologist,mean and median times on intubations #16-20 were compared for the two videolaryngoscopes.
Measured: 4 years
Time to Intubation, Stratified by Weight of Patients
To compare the time-to-intubation for these laryngoscopes in children of different weights.
Measured: 4 years
Mean Years Since Completion of Anesthesiology Residency
To investigate whether there was a correlation between the years since completion of anesthesiology residency to the mid-point of study (2008)and median time-to-intubation for all first attempt intubations for the study. Years since completion of anesthesiology residency reported in the data table, correlation reported in the statistical analysis below
Measured: Baseline (assessed as of 2008)
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
For each anesthesiologist, the median time-to-intubation for patients #1-5, #6-10, #11-15, and #16-20 was determined. The anesthesiologist was considered to have reached "Best Obtainable Time (BOT) to Intubation" once the median time on any group of 5 consecutive patients was less than 3 seconds faster than the median time in the previous group of 5 consecutive patients, provided that there were no failed intubations or subsequent failed intubations using the same device.
Measured: less than 5 minutes per intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startJan 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tracheal Intubation MorbidityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Verathon, KARL STORZ Endoscopy-America, Inc.
- Responsible party
- Principal investigator, Joan Robinson, University of Alberta
- Investigators
- Joan L Robinson, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215422
- Sponsor's protocol ID
- JR-01
- Status last verified
- Oct 2012
- First submitted
- 4 Oct 2010
- Last updated
- 8 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiologists Learning to Use Videolaryngoscopes in Children
- ClinicalTrials.gov ID
- NCT01215422
- Acronym / sponsor ID
- JR-01
- Conditions
- Tracheal Intubation Morbidity
- Keywords
- Surgical procedures, Intubation, Anesthesiologist, Laryngoscope, Videolaryngoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Verathon, KARL STORZ Endoscopy-America, Inc.
- Study start
- Jan 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 8 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two new instruments on the market that anesthesiologists use when putting a breathing tube into the lungs of patients. The purpose of this study is to see how easily anesthesiologists can learn to use them in children.
Detailed description
Each anesthesiologist performed 20 timed baseline intubations. They were then randomized to perform 20 timed intubations with one of the two new videolaryngoscopes followed by 20 with the other new videolaryngoscope. The goal was to see how quickly they could become proficient.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children intubated with Glidescope | – | Procedure: timed intubationchildren intubated with Glidescope |
| children intubated with DCI | – | Procedure: timed intubationchildren intubated with DCI |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children being intubated for surgery
Key inclusion criteria (2 listed)
- Children requiring intubation for elective or non-elective surgery
- Anesthesiologists who care for children at Stollery Children's Hospital
Key exclusion criteria (5 listed)
- Children with raised intracranial pressure
- Children with potential cervical spine injuries
- Children at risk for regurgitation because of a full stomach
- Children who were anticipated to have a difficult airway based on their physical appearance or previous experience were excluded.
- None
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 |
|---|---|---|
| timed intubationtimed intubation | Procedure or surgery | children intubated with DCI, children intubated with Glidescope |
Primary outcome
Success in Learning to Use a Videolaryngoscope(VLS)
Time frame: Up to 5 minutes per intubation
Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. "Rapid Success" was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . "Delayed Success" was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having "No Success".
5 secondary outcomes
Cormack & Lehane Score
Time frame: reported during intubation (up to 5 minutes)
Time to Intubation, Analyzed by Order of Laryngoscopes Used
Time frame: 4 years
Time to Intubation, Stratified by Weight of Patients
Time frame: 4 years
Mean Years Since Completion of Anesthesiology Residency
Time frame: Baseline (assessed as of 2008)
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
Time frame: less than 5 minutes per intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tracheal Intubation Morbidity
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
Not yet recruitingPhase 2/3
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
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.
Joan L Robinson, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation Morbidity, run by University of Alberta at 1 site in Canada.
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 2 inclusion and 5 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 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Success in Learning to Use a Videolaryngoscope(VLS) (time frame: Up to 5 minutes per intubation). 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 8 Oct 2012.