Need of Awake Intubation for Difficult AirwaysNCT02169232
Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation
A study testing Videolaryngoscope and Fiberoptic in people with Need of Awake Intubation for Difficult Airways, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Need of Awake Intubation for Difficult Airways
- What is being tested?
- Videolaryngoscope and Fiberoptic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Dec 2015
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital
Who cannot join
- moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
- inability to communicate in English or French
- contraindications to the drugs used in the study
Trial locations and contacts
1 site in 1 country.
Albert Moore, MD contact
Aly Elbahrawy, MD contact
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec
Albert Moore, MD, moore_albert@hotmail.com
About this study
Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. The video laryngoscope is a device that is similar to a conventional laryngoscope but uses a video system to visualize the larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal intubations in of obese patients. Patients undergoing laparoscopic gastric bypas andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or video assisted laryngoscopy. The investigators primary outcome will be the time required for successful intubation.
- Being tested
- Videolaryngoscope, Fiberoptic
- Keywords
- Awake intubation, Videolaryngoscope, Fiberoptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
Also called Intubation by Glidoscope
FiberopticDevice
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope | Active comparator | Intubation by videolaryngoscope Receives: Device: Videolaryngoscope |
| Fiberoptic | Active comparator | Intubation by fibroscope Receives: Device: Fiberoptic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required for successful intubation
The time required for successful intubation, which will be measured as the time from which the bronchoscope or videolaryngoscope is initially introduced into the oropharynx, until the time that CO2 is registered on the capnogram.
Measured: 10 minutes
Secondary outcomes (1)
Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Need of Awake Intubation for Difficult AirwaysStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Albert Moore, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169232
- Sponsor's protocol ID
- 13-443-SDR
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation
- ClinicalTrials.gov ID
- NCT02169232
- Acronym / sponsor ID
- 13-443-SDR
- Keywords
- Awake intubation, Videolaryngoscope, Fiberoptic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jun 2014 (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.
Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. The video laryngoscope is a device that is similar to a conventional laryngoscope but uses a video system to visualize the larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal intubations in of obese patients. Patients undergoing laparoscopic gastric bypas andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or video assisted laryngoscopy. The investigators primary outcome will be the time required for successful intubation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope | Active comparator | Device: VideolaryngoscopeIntubation by videolaryngoscope |
| Fiberoptic | Active comparator | Device: FiberopticIntubation by fibroscope |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital
Key exclusion criteria (3 listed)
- moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
- inability to communicate in English or French
- contraindications to the drugs used in the study
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 |
|---|---|---|
| VideolaryngoscopeAlso: Intubation by Glidoscope | Device | Videolaryngoscope |
| Fiberoptic | Device | Fiberoptic |
Primary outcome
The time required for successful intubation
Time frame: 10 minutes
The time required for successful intubation, which will be measured as the time from which the bronchoscope or videolaryngoscope is initially introduced into the oropharynx, until the time that CO2 is registered on the capnogram.
1 secondary outcome
Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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.
Albert Moore, MD contact
Aly Elbahrawy, MD contact
Albert Moore, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope and Fiberoptic in people with Need of Awake Intubation for Difficult Airways, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Moore, MD (moore_albert@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time required for successful intubation (time frame: 10 minutes). 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 23 Jun 2014.