Clinical trial NCT05239195: DirEct Versus VIdeo LaryngosCopE Trial
Official title: DirEct Versus VIdeo LaryngosCopE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Critical Illness
Emergency Airway Management
Tracheal intubation
Video laryngoscope
Direct laryngoscope
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2022-02-14
Enrollment: 1420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. Failure to intubate the trachea on the first attempt occurs in more than 10% of all tracheal intubation procedures performed in the emergency department (ED) and intensive care unit (ICU). Improving clinicians rate of intubation on the first attempt could reduce the risk of serious procedural complications.

In current clinical practice, two classes of laryngoscopes are commonly used to help clinicians view the larynx while intubating the trachea: a video laryngoscope (equipped with a camera and a video screen) and a direct laryngoscope (not equipped with a camera or video screen). For nearly all laryngoscopy and intubation procedures performed in current clinical practice, clinicians use either a video or a direct laryngoscope. Prior research has shown that use of a video laryngoscope improves the operator's view of the larynx compared to a direct laryngoscope. Whether use of a video laryngoscope increases the likelihood of successful intubation on the first attempt remains uncertain. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to laryngoscopy and intubation could improve the care clinicians deliver and patient outcomes.

Detailed description: Clinicians frequently perform tracheal intubation of critically ill patients in the emergency department (ED) or intensive care unit (ICU). In 10-20% of emergency tracheal intubations, clinicians are unable to intubate the trachea on the first attempt, which increases the risk of peri-intubation complications. Successful laryngoscopy and tracheal intubation requires using a laryngoscope to \[1\] visualize the larynx and vocal cords and \[2\] create a pathway through which an endotracheal tube can be advanced through the oropharynx and larynx and into the trachea.

In current clinical practice, two classes of laryngoscopes are commonly used by clinicians to view the larynx while intubating the trachea: a video laryngoscope (equipped with a camera and a video screen) and a direct laryngoscope (not equipped with a camera or video screen). Clinicians use either a video laryngoscope or a direct laryngoscope as standard of care for every laryngoscopy and intubation procedure performed in current clinical practice.

Direct Laryngoscope: The Macintosh direct laryngoscope consists of a battery-containing handle and a blade with a light source. The operator achieves a direct line of sight -from the operator's eye through the mouth to the larynx and trachea - by using the laryngoscope blade to displace the tongue and elevate the epiglottis.

Video Laryngoscope: Video laryngoscopes consist of a fiberoptic camera and light source near the tip of the laryngoscope blade, which transmits images to a video screen. The position of the camera near the tip of the laryngoscope blade facilitates visualization of the larynx and trachea.

Use of a video laryngoscope and use of a direct laryngoscope are both common, standard-of-care approaches the clinicians use to perform tracheal intubation in the ED and ICU in current clinical care.

Currently, it is unknown whether use of a video laryngoscope or use of a direct laryngoscope has any effect on successful intubation on the first attempt or any other outcome. Some prior research has raised the hypothesis that using a video laryngoscope would increase clinicians' rate of successful intubation on the first attempt by facilitating the view of the larynx. Some prior research has raised the hypothesis that using a direct laryngoscope would increase clinicians' rate of successful intubation on the first attempt by facilitating a clear pathway for placement of the tube through the mouth into the trachea.

To date, 8 small single-center randomized trials and one 371-patient multicenter randomized clinical trial have been conducted under waiver of or alteration of informed consent to compare use of a video vs a direct laryngoscope in the setting of emergency tracheal intubation in the ED or ICU. Two of these trials provide the most direct preliminary data for this proposal. The "Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU (FELLOW)" randomized clinical trial, conducted under waiver of informed consent, compared these two standard-of-care approaches during 150 emergency tracheal intubations at Vanderbilt University Medical Center, finding no difference in the rate of successful intubation on the first attempt between use of a video and use of a direct laryngoscope. The "McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in the Critical Care Unit (MACMAN)" randomized clinical trial among 371 critically ill adults found no difference between use of a video vs direct laryngoscope in the rate of successful intubation on the first attempt. However, a hypothesis-forming post-hoc exploratory analysis of peri-intubation complications suggested that use of a video laryngoscope may be associated with a higher rate of complications than direct laryngoscope (9.5% vs 2.8%, respectively, p=0.01). These trials were underpowered to rule out small but clinically significant differences in first pass success, and were limited to intubations performed by inexperienced trainees in one practice setting (intensive care units), but they demonstrated hypothesis-generating findings requiring validation in larger trials that reflect the full spectrum of settings, operator specialties, and operator experience levels in which emergency tracheal intubation is routinely performed.

Because of the imperative to optimize emergency tracheal intubation in clinical care, the common use of both video and direct laryngoscopes in current clinical practice, and the lack of definitive data from randomized trials to definitively inform whether use of a video laryngoscope or a direct laryngoscope effects the rate of successful intubation on the first attempt, examining whether one approach increases the odds of successful intubation on the first attempt represents an urgent research priority. To address this knowledge gap, the investigators propose to conduct a large, multicenter, randomized clinical trial comparing use of a video laryngoscope versus use of a direct laryngoscope with regard to successful intubation on the first attempt among critically ill adults undergoing tracheal intubation in the ED or ICU.

Eligibility criteria: Inclusion Criteria:

* Patient is located in a participating unit.
* Planned procedure is orotracheal intubation using a laryngoscope.
* Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit.

Exclusion Criteria:

* Patient is known to be less than 18 years old.
* Patient is known to be pregnant.
* Patient is known to be a prisoner.
* Immediate need for tracheal intubation precludes safe performance of study procedures.
* Operator has determined that use of a video laryngoscope or use of a direct laryngoscope is required or contraindicated for the optimal care of the patient.

Primary outcomes:
measure: Number of Intubations With Successful Intubation on the First Attempt
timeFrame: Duration of procedure (minutes)
Secondary outcomes:
measure: Number of Participants With Severe Complications of Tracheal Intubation
timeFrame: from induction to 2 minutes following tracheal intubation
Other outcomes:
measure: Duration of Laryngoscopy and Tracheal Intubation
timeFrame: Duration of procedure (minutes)
measure: Number of Laryngoscopy Attempts
timeFrame: Duration of procedure (minutes)
measure: Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube
timeFrame: Duration of procedure (minutes)
measure: Successful Intubation on the First Attempt Without a Severe Complication
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Reason for Failure to Intubate on the First Attempt
timeFrame: Duration of procedure (minutes)
measure: Operator-reported Aspiration
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Esophageal Intubation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Injury to the Teeth
timeFrame: from induction to 2 minutes following tracheal intubation
measure: ICU-free Days in the First 28 Days
timeFrame: 28 days
measure: Ventilator Free Days in the First 28 Days
timeFrame: 28 days
measure: All-cause In-hospital Mortality
timeFrame: 28 days
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: New Orleans
country: United States
facility: Ochsner Medical Center | Ochsner Health System
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Matthew W Semler, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Adit A Ginde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hennepin County Medical Center, Minneapolis
name: Matthew E Prekker, MD, MPH
role: STUDY_CHAIR
affiliation: Denver Health Medical Center
name: Stacy A Trent, MD, MPH
role: STUDY_CHAIR
affiliation: Hennepin County Medical Center, Minneapolis
name: Brian E Driver, MD
role: STUDY_CHAIR
affiliation: Vanderbilt University Medical Center
name: Jonathan D Casey, MD, MSc
role: STUDY_DIRECTOR
References: