Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1036 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-06-01

Brief Summary

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Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.

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Detailed Description

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The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh videolaryngoscope vs the hyperangulated videolaryngoscope during tracheal intubation in ICU patients.The hypothesis of the study is that tracheal intubation using the hyperangulated videolaryngoscope will improve the frequency of successful intubation on the first attempt in ICU patients requiring intubation in the intensive care unit.

Conditions

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Acute Respiratory Failure Intubation Intubation; Difficult or Failed Videolaryngoscopy Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Hyperangulated videolaryngoscope

Tracheal intubation facilitated by a hyperangulated videolaryngoscope

Group Type EXPERIMENTAL

Hyperangulated blade videolaryngoscope

Intervention Type DEVICE

For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.

Macintosh videolaryngoscope

Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade

Group Type ACTIVE_COMPARATOR

Macintosh blade videolaryngoscope

Intervention Type DEVICE

For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.

Interventions

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Hyperangulated blade videolaryngoscope

For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.

Intervention Type DEVICE

Macintosh blade videolaryngoscope

For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older.
* Admitted to an Intensive Care Unit.
* Need for tracheal intubation during the stay in the ICU.
* The device to be used for intubation is a videolaryngoscope

Exclusion Criteria

* Pregnancy or lactation.
* Emergent tracheal intubation that does not allow for the randomization of the procedure.
* Need for tracheal intubation with a device other than the videolaryngoscope (fiberoptic bronchoscope, direct laryngoscopy, tracheostomy, etc.).
* Tracheal intubation performed outside the ICU (Emergency Department, Hospital ward, etc.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Manuel Taboada Muñiz

Professor Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Taboada, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Clinical Hospital of Santiago de Compostela

Locations

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University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Site Status RECRUITING

Complexo Hospitalario Universitario de A Coruña

A Coruña, , Spain

Site Status RECRUITING