McGRATH vs Macintosh Laryngoscopy Comparison in LMA Insertion (GRAN-PALM)

December 14, 2020 updated by: Christopher Ryalino, Udayana University

Comparison Between McGRATH and Macintosh Laryngoscopy in Laryngeal Mask Airway Insertion

Various techniques have been developed to get a good LMA position, one of them is using a laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type. Technological developments have brought laryngoscopes into the video era, one of which is McGRATH's laryngoscope, which from several studies about having an advantage in terms of the first attempt, time, complications, and hemodynamic stability of intubation. It needs to be proven through research on the comparison of clinical outcomes of LMA installation with McGrath laryngoscope and Macintosh laryngoscope.

Study Overview

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bali
      • Denpasar, Bali, Indonesia, 80114
        • Sanglah General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients underwent surgery with general anesthesia by LMA insertion in Sanglah General Hospital
  • Agreed to be included in the study by signing informed consent
  • American Society of Anesthesiologist physical status 1-2

Exclusion Criteria:

  • Patients unfit for LMA insertion
  • Patients with suspected airway management difficulty
  • Pregnancy
  • Morbid obese

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macintosh
Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy
Other Names:
  • Group G
Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
Other Names:
  • Group I
Experimental: McGRATH
Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy
Other Names:
  • Group G
Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
Other Names:
  • Group I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with first-attempt success
Time Frame: immediately after LMA insertion
Successful LMA insertion within first attempt
immediately after LMA insertion
Mean arterial pressure
Time Frame: immediately after LMA insertion
Mean arterial pressure measured by non-invasive blood pressure monitor
immediately after LMA insertion
Heart rate
Time Frame: immediately after LMA insertion
Heart rate measured by standard monitor
immediately after LMA insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required
Time Frame: immediately after LMA insertion
Time required for LMA insertion using the respective method
immediately after LMA insertion
Complications
Time Frame: An hour after the the end of surgery
Incidence of hoarseness or throat pain due to LMA insertion
An hour after the the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UNUD-CTR-FK270720-003
  • 1320/UN14.2.2.VII.14/LT/2020 (Other Identifier: Committee of Ethical Research of Udayana University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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