DirEct Versus VIdeo LaryngosCopE Trial (DEVICE)

• ClinicalTrials.gov Identifier: NCT05239195
• Recruitment Status: Completed
• First Posted: February 14, 2022
• Last Update Posted: December 29, 2022
• Sponsor: Vanderbilt University Medical Center
• Collaborator: University of Colorado, Denver
• Information provided by (Responsible Party): Jonathan Casey, Vanderbilt University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Failure	Other: Video Laryngoscope; Other: Direct Laryngoscope	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: DirEct Versus VIdeo LaryngosCopE Trial
• Actual Study Start Date: March 19, 2022
• Actual Primary Completion Date: November 17, 2022
• Actual Study Completion Date: December 16, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Video Laryngoscope Group; For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.	Other: Video Laryngoscope; Laryngoscope with a camera and a video screen
Active Comparator: Direct Laryngoscope Group; For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.	Other: Direct Laryngoscope; Laryngoscope without a camera or a video screen

Outcome Measures

Primary Outcome Measures :

1. Number of intubations with successful intubation on the first attempt [ Time Frame: Duration of procedure (minutes) ]
   The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.

Secondary Outcome Measures :

1. Severe complications of tracheal intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]

   The secondary outcome is defined as one or more of the following occurring between induction and 2 minutes after successful intubation:

   • Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry < 80%);
   • Severe hypotension (systolic blood pressure < 65 mm Hg or new or increased vasopressor administration);
   • Cardiac arrest not resulting in death within 1 hour of intubation; or
   • Cardiac arrest resulting in death within 1 hour of induction

Other Outcome Measures:

1. Duration of laryngoscopy and tracheal intubation [ Time Frame: Duration of procedure (minutes) ]
   The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of an endotracheal tube or tracheostomy tube in the trachea.
2. Number of laryngoscopy attempts [ Time Frame: Duration of procedure (minutes) ]
3. Number of attempts to cannulate the trachea with a bougie or an endotracheal tube [ Time Frame: Duration of procedure (minutes) ]
4. Successful intubation on the first attempt without a severe complication [ Time Frame: from induction to 2 minutes following tracheal intubation ]
   Composite of patients who meet the primary outcome (successful intubation on the first attempt) without meeting the secondary outcome (severe complications of tracheal intubation)
5. Reason for failure to intubate on the first attempt [ Time Frame: Duration of procedure (minutes) ]

   Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):

   • Inadequate view of the larynx
   • Inability to intubate the trachea with an endotracheal tube
   • Inability to cannulate the trachea with a bougie
   • Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding)
   • Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)
   • Other
6. Operator-reported aspiration [ Time Frame: from induction to 2 minutes following tracheal intubation ]
7. Esophageal intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
8. Injury to the teeth [ Time Frame: from induction to 2 minutes following tracheal intubation ]
9. ICU-free days in the first 28 days [ Time Frame: 28 days ]
10. Ventilator free days in the first 28 days [ Time Frame: 28 days ]
11. All-cause in-hospital mortality [ Time Frame: 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

UAB Hospital

Birmingham, Alabama, United States, 35233

United States, Colorado

University of Colorado Denver

Aurora, Colorado, United States, 80045

Denver Health Medical Center

Denver, Colorado, United States, 80204

United States, Louisiana

Ochsner Medical Center | Ochsner Health System

New Orleans, Louisiana, United States, 70112

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Baylor Scott & White Health

Temple, Texas, United States, 76508

United States, Washington

Harborview Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Vanderbilt University Medical Center

University of Colorado, Denver

Investigators

• Principal Investigator: Matthew W Semler, MD, MSc; Vanderbilt University Medical Center
• Principal Investigator: Adit A Ginde, MD, MPH; University of Colorado, Denver
• Study Chair: Matthew E Prekker, MD, MPH; Hennepin County Medical Center, Minneapolis
• Study Chair: Stacy A Trent, MD, MPH; Denver Health Medical Center
• Study Chair: Brian E Driver, MD; Hennepin County Medical Center, Minneapolis
• Study Director: Jonathan D Casey, MD, MSc; Vanderbilt University Medical Center

More Information

• Responsible Party: Jonathan Casey, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT05239195
• Other Study ID Numbers: 211272
• First Posted: February 14, 2022
• Last Update Posted: December 29, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Following publication. No end date

Access Criteria

1. a signed data access agreement
2. research testing a hypothesis
3. a protocol that has been approved by an institutional review board
4. a proposal that has received approval from the principal investigator

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Casey, Vanderbilt University Medical Center:

Critical Illness; Emergency Airway Management; Tracheal intubation; Video laryngoscope; Direct laryngoscope

Additional relevant MeSH terms:

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases