Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

Intubation Clinical Trial

Official title:

Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701762
• Other study ID #: 19-1158
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Intubation
• Laryngoscopy

Intervention

Device:
• GlideScope videolaryngoscope (Verathon, Bothell, WA 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, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
• Direct laryngoscopy
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);

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

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