Videolaryngoscopy Compared to Direct Laryngoscopy

NCT ID: NCT04794764

Last Updated: 2024-01-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-24

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Aspiration of Gastric Contents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

McGrath MAC

First pass success rate using the McGrath Mac

Group Type EXPERIMENTAL

McGrath Mac

Intervention Type DEVICE

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Macintosh Laryngoscope

First pass success rate using the Macintosh laryngoscope

Group Type EXPERIMENTAL

Macintosh Laryngoscope

Intervention Type DEVICE

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

McGrath Mac

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Intervention Type DEVICE

Macintosh Laryngoscope

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 Years
* capacity to consent
* Present written informed consent of the research participant

Exclusion Criteria

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* Difficult Airway / Defined Indications for awake intubation
* Participation in another study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Krankenhaus der Borromaerinnen Trier

UNKNOWN

Sponsor Role collaborator

University Medical Center Freiburg

OTHER

Sponsor Role collaborator

BundeswehrZentralkrankenhaus Koblenz

OTHER

Sponsor Role collaborator

Krankenhaus Hetzelstift

OTHER

Sponsor Role collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marc Kriege, MD

PD Dr. med. habil. Marc Kriege

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Kriege, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University JG, Mainz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Kriege M, Lang P, Lang C, Pirlich N, Griemert EV, Heid F, Wittenmeier E, Schmidtmann I, Schmidbauer W, Janig C, Jungbecker J, Kunitz O, Strate M, Schmutz A. Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol. BMJ Open. 2021 Oct 6;11(10):e052977. doi: 10.1136/bmjopen-2021-052977.

Reference Type DERIVED
PMID: 34615684 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JohannesGUV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.