Intubation; DifficultNCT02387502
Comparison of Three Laryngoscopes in Difficult Laryngoscopy
A study testing Intubation- Macintosh laryngoscope, Intubation- MacCoy laryngoscope and Intubation- Airtraq laryngoscope in people with Intubation; Difficult, run by Government Medical College, Haldwani.
Trial summary
Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Intubation- Macintosh laryngoscope, Intubation- MacCoy laryngoscope and Intubation- Airtraq laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- 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
- American Society of Anesthesiologists (ASA) physical status I and II.
- Posted for elective surgery requiring general anesthesia and tracheal intubation
Who cannot join
- patients with anticipated difficult airway
- obese (body mass index (BMI)>30) patients
- patients with risk of pulmonary aspiration of gastric contents
- pregnant patients
- patients with airway distortion or trauma.
About this study
Official title: Comparative Evaluation of Macintosh, MacCoy and Airtraq Laryngoscope in Simulated Difficult Laryngoscopy Using Rigid Neck Collar
Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.
Read the detailed description
Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma.
- Conditions
- Intubation; Difficult
- Being tested
- Intubation- Macintosh laryngoscope, Intubation- MacCoy laryngoscope, Intubation- Airtraq laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation- Macintosh laryngoscopeDevice
Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
Intubation- MacCoy laryngoscopeDevice
In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
Intubation- Airtraq laryngoscopeDevice
In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
| Study group | Role | What they receive |
|---|---|---|
| Intubation with Macintosh laryngoscope | Experimental | 40 patients were intubated with Macintosh laryngoscope after simulating difficult laryngoscopy using rigid neck collar. Receives: Device: Intubation- Macintosh laryngoscope |
| Intubation with MacCoy laryngoscope | Active comparator | 40 patients were intubated with MacCoy laryngoscope after simulating difficult laryngoscopy using rigid neck collar. Receives: Device: Intubation- MacCoy laryngoscope |
| Intubation with Airtraq laryngoscope | Active comparator | 40 patients were intubated with Airtraq laryngoscope after simulating difficult laryngoscopy using rigid neck collar. Receives: Device: Intubation- Airtraq laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Intubation
Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Intubation; DifficultStudies 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, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Haldwani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bikramjit Das, Government Medical College, Haldwani
- Investigators
- Geeta Bhandari, M.D., Principal investigator, Professor, Department of Anesthesiology, G.M.C. Haldwani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387502
- Sponsor's protocol ID
- 123-IEC/01/13
- Status last verified
- Apr 2015
- First submitted
- 2 Mar 2015
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Macintosh, MacCoy and Airtraq Laryngoscope in Simulated Difficult Laryngoscopy Using Rigid Neck Collar
- ClinicalTrials.gov ID
- NCT02387502
- Acronym / sponsor ID
- 123-IEC/01/13
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Government Medical College, HaldwaniUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.
Detailed description
Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubation with Macintosh laryngoscope | Experimental | Device: Intubation- Macintosh laryngoscope40 patients were intubated with Macintosh laryngoscope after simulating difficult laryngoscopy using rigid neck collar. |
| Intubation with MacCoy laryngoscope | Active comparator | Device: Intubation- MacCoy laryngoscope40 patients were intubated with MacCoy laryngoscope after simulating difficult laryngoscopy using rigid neck collar. |
| Intubation with Airtraq laryngoscope | Active comparator | Device: Intubation- Airtraq laryngoscope40 patients were intubated with Airtraq laryngoscope after simulating difficult laryngoscopy using rigid neck collar. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I and II.
- Posted for elective surgery requiring general anesthesia and tracheal intubation
Key exclusion criteria (5 listed)
- patients with anticipated difficult airway
- obese (body mass index (BMI)>30) patients
- patients with risk of pulmonary aspiration of gastric contents
- pregnant patients
- patients with airway distortion or trauma.
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 |
|---|---|---|
| Intubation- Macintosh laryngoscopeDifficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated. | Device | Intubation with Macintosh laryngoscope |
| Intubation- MacCoy laryngoscopeIn MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated. | Device | Intubation with MacCoy laryngoscope |
| Intubation- Airtraq laryngoscopeIn Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed. | Device | Intubation with Airtraq laryngoscope |
Primary outcome
Time of Intubation
Time frame: up to 10 minutes
Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Geeta Bhandari, M.D. principal investigator
Professor, Department of Anesthesiology, G.M.C. Haldwani
Questions about this trial
What is this clinical trial studying?
A study testing Intubation- Macintosh laryngoscope, Intubation- MacCoy laryngoscope and Intubation- Airtraq laryngoscope in people with Intubation; Difficult, run by Government Medical College, Haldwani.
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 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 May 2015). 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?
Time of Intubation (time frame: up to 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 4 May 2015.