Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

Not Applicable

Completed

• Conditions: Intubation; Laryngoscopy
• Interventions: Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011); Device: Direct laryngoscopy

• Registration Number: NCT04701762
• Lead Sponsor: The Cleveland Clinic

Brief 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. 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.

The investigators plan a cluster randomized multiple crossover design, where each cluster is crossed over to the other treatment in the next period. The operating suites will be divided into 2 separate clusters consisting of 11 operating suites each. Randomization will consist of randomizing cluster 1 to use either video laryngoscope or direct laryngoscope, and cluster 2 to the alternative device in one-week blocks.

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2021-03-01
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12701

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
videolaryngoscopy	GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)	Initial intubation performed using GlideScope videolaryngoscope.
conventional direct laryngoscopy	Direct laryngoscopy	Initial intubation performed using direct laryngoscopy.

Primary Outcome Measures

Name	Time	Method
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.	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.

Secondary Outcome Measures

Name	Time	Method
Intubation Failure	From the start time of intubation to time of the end of surgery.	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.
Any Dental or Airway Injury	From the start time of intubation to time of the end of surgery.	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States