Clinical trial NCT04701762: Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy
Official title: Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Laryngoscopy
Keywords: Airway
Videolaryngoscope
Direct Laryngoscope
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 7736
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster randomized multiple crossover design
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
timeFrame: From the start time of intubation to time of the end of surgery up to 24 hours.
Secondary outcomes:
measure: Intubation Failure
timeFrame: From the start time of intubation to time of the end of surgery.
measure: Any Dental or Airway Injury
timeFrame: From the start time of intubation to time of the end of surgery.
Other outcomes:
measure: Maximum Mean Arterial Pressure
timeFrame: In five minutes after intubation.
measure: Maximum Heart Rate (HR)
timeFrame: In five minutes after intubation
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kurt Ruetzler, MD
role: PRINCIPAL_INVESTIGATOR
References: