McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

NCT ID: NCT05850052

Last Updated: 2025-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-07

Study Completion Date

2024-08-05

Brief Summary

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The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Detailed Description

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The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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McGrath Videolaryngoscope for rapid endotracheal intubation

The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Group Type EXPERIMENTAL

McGrath videolaryngoscope for rapid sequence endotracheal intubation

Intervention Type DEVICE

Visualize a patient's airway to aid placement of tracheal tube with ease.

Efficacy of conventional direct laryngoscopy

The researchers seek to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade.

Group Type OTHER

Conventional direct laryngoscopy using a Macintosh blade

Intervention Type DEVICE

Examine a patient's airway to aid placement of tracheal tube with ease.

Interventions

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McGrath videolaryngoscope for rapid sequence endotracheal intubation

Visualize a patient's airway to aid placement of tracheal tube with ease.

Intervention Type DEVICE

Conventional direct laryngoscopy using a Macintosh blade

Examine a patient's airway to aid placement of tracheal tube with ease.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elective surgery requiring oral endotracheal intubation for general anesthesia;
* Anticipated extubation in the operating room;
* American Society of Anesthesiologists (ASA) physical status 2-3;
* Age between 18 and 99 years;
* Body Mass index ≥ 40 kg/m2.

Exclusion Criteria

* Refusal of participation by attending anesthesiologist;
* Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
* Indicated fiberoptic awake intubation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt Ruetzler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,

Istanbul, , Turkey (Türkiye)

Site Status

The University of Health Science, Konya City Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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McGrady Study

Identifier Type: -

Identifier Source: org_study_id

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