Intubation Clinical Trial
Official title:
Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial
NCT number | NCT04701762 |
Other study ID # | 19-1158 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | December 23, 2022 |
Verified date | January 2024 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 12701 |
Est. completion date | December 23, 2022 |
Est. primary completion date | December 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia. Exclusion Criteria: - The attending anesthesiologist prefers a specific approach for a particular patient - Awake fiberoptic intubation is clinically indicated - Insertion of double-lumen tube. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From the start time of intubation to time of the end of surgery up to 45 minutes | |
Secondary | 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. | From the start time of intubation to time of the end of surgery up to 45 minutes | |
Secondary | 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. |
From the start time of intubation to time of the end of surgery up to 45 minutes |
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