DirEct Versus VIdeo LaryngosCopE Trial

Acute Respiratory Failure Clinical Trial

— DEVICE  

Official title:

DirEct Versus VIdeo LaryngosCopE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239195
• Other study ID #: 211272
• Status: Completed
• Phase: N/A
• Start date: March 19, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: December 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1420
• Est. completion date: December 16, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Video Laryngoscope
Laryngoscope with a camera and a video screen
• Direct Laryngoscope
Laryngoscope without a camera or a video screen

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	UAB Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Denver Health Medical Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Medical Center | Ochsner Health System	New Orleans	Louisiana
United States	Harborview Medical Center	Seattle	Washington
United States	Baylor Scott & White Health	Temple	Texas
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of laryngoscopy and tracheal intubation	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.	Duration of procedure (minutes)
Other	Number of laryngoscopy attempts		Duration of procedure (minutes)
Other	Number of attempts to cannulate the trachea with a bougie or an endotracheal tube		Duration of procedure (minutes)
Other	Successful intubation on the first attempt without a severe complication	Composite of patients who meet the primary outcome (successful intubation on the first attempt) without meeting the secondary outcome (severe complications of tracheal intubation)	from induction to 2 minutes following tracheal intubation
Other	Reason for failure to intubate on the first attempt	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	Duration of procedure (minutes)
Other	Operator-reported aspiration		from induction to 2 minutes following tracheal intubation
Other	Esophageal intubation		from induction to 2 minutes following tracheal intubation
Other	Injury to the teeth		from induction to 2 minutes following tracheal intubation
Other	ICU-free days in the first 28 days		28 days
Other	Ventilator free days in the first 28 days		28 days
Other	All-cause in-hospital mortality		28 days
Primary	Number of intubations with successful intubation on the first attempt	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.	Duration of procedure (minutes)
Secondary	Severe complications of 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	from induction to 2 minutes following tracheal intubation