Intubation, EndotrachealPhase 4NCT00917033
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy
A Phase 4 study testing GlideScope and Macintosh direct laryngoscope in people with Intubation, Endotracheal and Anesthesia, General, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation, Endotracheal, Anesthesia, General, Obesity
- What is being tested?
- GlideScope and Macintosh direct laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to Oct 2009
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
- Body Mass Index at least 35 kg/m2
- Written informed consent to participate
Who cannot join
- Mental illness
- Abuse of alcohol or other substances
- Previous difficult tracheal intubation
- Considered non-eligible for safety-reasons by the anesthetist in charge
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesia, Glostrup University Hospital
Copenhagen, Glostrup, DK-2600
About this study
Official title: Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.
The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.
- Conditions
- Intubation, Endotracheal, Anesthesia, General, Obesity
- Being tested
- GlideScope, Macintosh direct laryngoscope
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScopeDevice
Orotracheal intubation
Macintosh direct laryngoscopeDevice
Orotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| GlideScope | Experimental | Orotracheal intubation using the GlideScope videolaryngoscope Receives: Device: GlideScope |
| Macintosh | Active comparator | Orotracheal intubation using the Macintosh direct laryngoscope Receives: Device: Macintosh direct laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubate
Measured: Measured during intubation (seconds)
Secondary outcomes (8)
Number of intubation attempts
Measured: Measured during intubation (seconds)
Lowest arterial oxygen saturation during intubation
Measured: Measured during intubation (seconds)
Subjective difficulty of intubation
Measured: Measured during intubation (seconds)
Cormack-Lehane Score
Measured: Measured during intubation (seconds)
Airway mucosal trauma
Measured: Measured during intubation (seconds)
Dental injury
Measured: Measured during intubation (seconds)
Post-procedure sore throat
Measured: One hour post-operative
Post-procedure hoarseness of voice
Measured: One hour post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, EndotrachealStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Lasse H Andersen, MD, Principal investigator, Glostrup University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917033
- Sponsor's protocol ID
- LHA GS 01
- Status last verified
- Feb 2010
- First submitted
- 9 Jun 2009
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.
- ClinicalTrials.gov ID
- NCT00917033
- Acronym / sponsor ID
- LHA GS 01
- Conditions
- Intubation, Endotracheal, Anesthesia, General, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Jun 2009 (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 examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GlideScope | Experimental | Device: GlideScopeOrotracheal intubation using the GlideScope videolaryngoscope |
| Macintosh | Active comparator | Device: Macintosh direct laryngoscopeOrotracheal intubation using the Macintosh direct laryngoscope |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
- Body Mass Index at least 35 kg/m2
- Written informed consent to participate
Key exclusion criteria (4 listed)
- Mental illness
- Abuse of alcohol or other substances
- Previous difficult tracheal intubation
- Considered non-eligible for safety-reasons by the anesthetist in charge
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 |
|---|---|---|
| GlideScopeOrotracheal intubation | Device | GlideScope |
| Macintosh direct laryngoscopeOrotracheal intubation | Device | Macintosh |
Primary outcome
Time to intubate
Time frame: Measured during intubation (seconds)
8 secondary outcomes
Number of intubation attempts
Time frame: Measured during intubation (seconds)
Lowest arterial oxygen saturation during intubation
Time frame: Measured during intubation (seconds)
Subjective difficulty of intubation
Time frame: Measured during intubation (seconds)
Cormack-Lehane Score
Time frame: Measured during intubation (seconds)
Airway mucosal trauma
Time frame: Measured during intubation (seconds)
Dental injury
Time frame: Measured during intubation (seconds)
Post-procedure sore throat
Time frame: One hour post-operative
Post-procedure hoarseness of voice
Time frame: One hour post-operative
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 24 Feb 2010.
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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.
Lasse H Andersen, MD principal investigator
Glostrup University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GlideScope and Macintosh direct laryngoscope in people with Intubation, Endotracheal and Anesthesia, General, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 3 inclusion and 4 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 24 Feb 2010. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to intubate (time frame: Measured during intubation (seconds)). 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 24 Feb 2010.