SurgeryNCT05850052
McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation
A study testing McGrath videolaryngoscope for rapid sequence endotracheal intubation and Conventional direct laryngoscopy using a Macintosh blade in people with Surgery, run by The Cleveland Clinic at 2 sites in Turkey (Türkiye).
Trial summary
The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgery
- What is being tested?
- McGrath videolaryngoscope for rapid sequence endotracheal intubation and Conventional direct laryngoscopy using a Macintosh blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 May 2023to 5 Aug 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Anticipated extubation in the operating room;
- American Society of Anesthesiologists (ASA) physical status 2-3;
- Age between 18 and 99 years;
- Body Mass index ≥ 40 kg/m2.
Who cannot join
- Refusal of participation by attending anesthesiologist;
- Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
- Indicated fiberoptic awake intubation.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,
Istanbul
The University of Health Science, Konya City Hospital
Konya
About this study
Official title: Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial
The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
Read the detailed description
The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
- Conditions
- Surgery
- Being tested
- McGrath videolaryngoscope for rapid sequence endotracheal intubation, Conventional direct laryngoscopy using a Macintosh blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath videolaryngoscope for rapid sequence endotracheal intubationDevice
Visualize a patient's airway to aid placement of tracheal tube with ease.
Conventional direct laryngoscopy using a Macintosh bladeDevice
Examine a patient's airway to aid placement of tracheal tube with ease.
| Study group | Role | What they receive |
|---|---|---|
| McGrath Videolaryngoscope for rapid endotracheal intubation | Experimental | The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. Receives: Device: McGrath videolaryngoscope for rapid sequence endotracheal intubation |
| Efficacy of conventional direct laryngoscopy | Other | The researchers seek to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade. Receives: Device: Conventional direct laryngoscopy using a Macintosh blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of the Vocal Cords
The visualization of the vocal cords, defined using the modified Cormack and Lehane classification:
Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible).
Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen).
Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).
Measured: From the start time of intubation to time of the end of surgery, up to 12 hours.
Secondary outcomes (2)
Number of Participants With 1, 2, 3, and 4 Intubation Attempts
An intubation attempt was recorded once the endotracheal tube entered the oral cavity
Measured: From the start time of intubation to time of the end of surgery, up to 12 hours.
Intubation Failure.
Intubation was considered a failure if there was: (1) a failure to intubate after 3 attempts, (2) the need to switch intubators or intubation device, or (3) the need to stop study per anesthesiologist's discretion.
Measured: From the start time of intubation to time of the end of surgery, up to 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start7 May 2023
- Primary completion5 Jun 2024
- Study completion5 Aug 2024
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 SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Ruetzler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850052
- Sponsor's protocol ID
- McGrady Study
- Status last verified
- Jan 2025
- First submitted
- 25 Apr 2023
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT05850052
- Acronym / sponsor ID
- McGrady Study
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 7 May 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
Detailed description
The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath Videolaryngoscope for rapid endotracheal intubation | Experimental | Device: McGrath videolaryngoscope for rapid sequence endotracheal intubationThe researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. |
| Efficacy of conventional direct laryngoscopy | Other | Device: Conventional direct laryngoscopy using a Macintosh bladeThe researchers seek to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Anticipated extubation in the operating room;
- American Society of Anesthesiologists (ASA) physical status 2-3;
- Age between 18 and 99 years;
- Body Mass index ≥ 40 kg/m2.
Key exclusion criteria (3 listed)
- Refusal of participation by attending anesthesiologist;
- Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
- Indicated fiberoptic awake intubation.
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 |
|---|---|---|
| McGrath videolaryngoscope for rapid sequence endotracheal intubationVisualize a patient's airway to aid placement of tracheal tube with ease. | Device | McGrath Videolaryngoscope for rapid endotracheal intubation |
| Conventional direct laryngoscopy using a Macintosh bladeExamine a patient's airway to aid placement of tracheal tube with ease. | Device | Efficacy of conventional direct laryngoscopy |
Primary outcome
Visualization of the Vocal Cords
Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
The visualization of the vocal cords, defined using the modified Cormack and Lehane classification: Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible). Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen). Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).
2 secondary outcomes
Number of Participants With 1, 2, 3, and 4 Intubation Attempts
Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
Intubation Failure.
Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- 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.
Kurt Ruetzler, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGrath videolaryngoscope for rapid sequence endotracheal intubation and Conventional direct laryngoscopy using a Macintosh blade in people with Surgery, run by The Cleveland Clinic at 2 sites in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 3 Feb 2025. 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 Turkey (Türkiye). 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 3 Feb 2025). 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?
Visualization of the Vocal Cords (time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.). 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 3 Feb 2025.