IntubationNCT04701762
Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy
A study testing GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) and Direct laryngoscopy in people with Intubation and Laryngoscopy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intubation, Laryngoscopy
- What is being tested?
- GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) and Direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,736 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 23 Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.
Who cannot join
- The attending anesthesiologist prefers a specific approach for a particular patient
- Awake fiberoptic intubation is clinically indicated
- Insertion of double-lumen tube.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial
The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified
Read the detailed description
The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.
A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.
- Conditions
- Intubation, Laryngoscopy
- Being tested
- GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011), Direct laryngoscopy
- Keywords
- Airway, Videolaryngoscope, Direct Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)Device
After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, Washington 98011) is an FDA-cleared commercially available portable videolaryngoscope.
Direct laryngoscopyDevice
After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
| Study group | Role | What they receive |
|---|---|---|
| videolaryngoscopy | Experimental | Initial intubation performed using GlideScope videolaryngoscope. Receives: Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) |
| conventional direct laryngoscopy | Active comparator | Initial intubation performed using direct laryngoscopy. Receives: Device: Direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
Measured: From the start time of intubation to time of the end of surgery up to 24 hours.
Secondary outcomes (2)
Intubation Failure
Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts.
Measured: From the start time of intubation to time of the end of surgery.
Any Dental or Airway Injury
Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team.
Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team.
Measured: From the start time of intubation to time of the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Mar 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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
- Crossover
- Model description
- Cluster randomized multiple crossover design
- Masking
- None (open label)
- Enrolment
- 7,736 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
- NCT04701762
- Sponsor's protocol ID
- 19-1158
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ruetzler K, Bustamante S, Schmidt MT, Almonacid-Cardenas F, Duncan A, Bauer A, Turan A, Skubas NJ, Sessler DI; Collaborative VLS Trial Group. Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial. JAMA. 2024 Apr 16;331(15):1279-1286. doi: 10.1001/jama.2024.0762.
PubMed 38497992
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial
- ClinicalTrials.gov ID
- NCT04701762
- Acronym / sponsor ID
- 19-1158
- Conditions
- Intubation, Laryngoscopy
- Keywords
- Airway, Videolaryngoscope, Direct Laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,736 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified
Detailed description
The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.
A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized multiple crossover design
| Arm | Type | Receives |
|---|---|---|
| videolaryngoscopy | Experimental | Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)Initial intubation performed using GlideScope videolaryngoscope. |
| conventional direct laryngoscopy | Active comparator | Device: Direct laryngoscopyInitial intubation performed using direct laryngoscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.
Key exclusion criteria (3 listed)
- The attending anesthesiologist prefers a specific approach for a particular patient
- Awake fiberoptic intubation is clinically indicated
- Insertion of double-lumen tube.
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 |
|---|---|---|
| GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, Washington 98011) is an FDA-cleared commercially available portable videolaryngoscope. | Device | videolaryngoscopy |
| Direct laryngoscopyAfter confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4); | Device | conventional direct laryngoscopy |
Primary outcome
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
Time frame: From the start time of intubation to time of the end of surgery up to 24 hours.
Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
2 secondary outcomes
Intubation Failure
Time frame: From the start time of intubation to time of the end of surgery.
Any Dental or Airway Injury
Time frame: From the start time of intubation to time of the end of surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38497992Ruetzler K, Bustamante S, Schmidt MT, Almonacid-Cardenas F, Duncan A, Bauer A, Turan A, Skubas NJ, Sessler DI; Collaborative VLS Trial Group. Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial. JAMA. 2024 Apr 16;331(15):1279-1286. doi: 10.1001/jama.2024.0762.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) and Direct laryngoscopy in people with Intubation and Laryngoscopy, run by The Cleveland Clinic at 1 site in United States.
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: finished, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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 19 Sep 2024). 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?
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. (time frame: From the start time of intubation to time of the end of surgery up to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04701762, which also lists 1 linked publication.
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 19 Sep 2024.