Morbidly ObeseNCT01237080
Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM
A study testing GlideScope and Fastrach in people with Morbidly Obese and Intubationtime, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
Trial summary
The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbidly Obese, Intubationtime, Intubationattempts
- What is being tested?
- GlideScope and Fastrach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2010to Jan 2011
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI >/= 35
Who cannot join
- need for crash induction.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Anesthesiology, Copenhagen University Hospital
Glostrup, Region Sjælland, 2600
Privathospitalet Hamlet
Soeborg, Region Sjælland, 2860
About this study
Official title: Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.
The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.
The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.
Read the detailed description
The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.
Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.
- Conditions
- Morbidly Obese, Intubationtime, Intubationattempts
- Being tested
- GlideScope, Fastrach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScopeDevice
The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.
FastrachDevice
The Fastrach is an intubation laryngeal mask.
| Study group | Role | What they receive |
|---|---|---|
| Fastrach | Experimental | 50 persons beeing intubated using the Fastrach. Receives: Device: Fastrach |
| GlideScope | Experimental | 50 persons beeing intubated using the GlideScope. Receives: Device: GlideScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Intubated in the First Attempt
The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).
Measured: please see description
Time to Intubate
Measured: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
Secondary outcomes (6)
Lowest Saturation During Intubation.
Measured: measured on the monitor
Mucosal Lesion
Measured: inspection during intubation and one hour postop.
Subjectively Intubation Difficulty
Measured: measured immediately on a visual analogue scale.
Intubation of the Esophagus.
Measured: detected immediately
Postoperative Hoarseness.
Measured: one hour postoperative.
Postoperative Throat Pain.
Measured: one hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJan 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 Morbidly ObeseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mogens Ydemann Nielsen, Glostrup University Hospital, Copenhagen
- Investigators
- Mogens VY Nielsen, MD, Principal investigator, Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237080
- Sponsor's protocol ID
- H-1-2010-058
- Status last verified
- Jan 2013
- First submitted
- 8 Nov 2010
- Last updated
- 20 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.
- ClinicalTrials.gov ID
- NCT01237080
- Acronym / sponsor ID
- H-1-2010-058
- Conditions
- Morbidly Obese, Intubationtime, Intubationattempts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 20 Feb 2013
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 compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.
The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.
Detailed description
The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.
Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fastrach | Experimental | Device: Fastrach50 persons beeing intubated using the Fastrach. |
| GlideScope | Experimental | Device: GlideScope50 persons beeing intubated using the GlideScope. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI >/= 35
Key exclusion criteria (1 listed)
- need for crash induction.
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 |
|---|---|---|
| GlideScopeThe GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope. | Device | GlideScope |
| FastrachThe Fastrach is an intubation laryngeal mask. | Device | Fastrach |
Primary outcome
Number of Patients Intubated in the First Attempt
Time frame: please see description
The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).
Time to Intubate
Time frame: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
6 secondary outcomes
Lowest Saturation During Intubation.
Time frame: measured on the monitor
Mucosal Lesion
Time frame: inspection during intubation and one hour postop.
Subjectively Intubation Difficulty
Time frame: measured immediately on a visual analogue scale.
Intubation of the Esophagus.
Time frame: detected immediately
Postoperative Hoarseness.
Time frame: one hour postoperative.
Postoperative Throat Pain.
Time frame: one hour postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Morbidly Obese
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High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
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Videolaryngoscopes in the Morbidly Obese
Obesity Difficult Airway Airway Management
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Airway Scope vs GlideScope for Intubation in Obese Patients
Intratracheal Inbubation
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Induction of Labor in Morbidly Obese Patients
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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.
Mogens VY Nielsen, MD principal investigator
Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope and Fastrach in people with Morbidly Obese and Intubationtime, run by Glostrup University Hospital, Copenhagen at 2 sites 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 1 inclusion and 1 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2013). 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?
Number of Patients Intubated in the First Attempt (time frame: please see description). The study lists 2 primary outcomes in all. 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 20 Feb 2013.