- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509453
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
Status
Completed
Intervention / Treatment
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:
Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
Other Names:
|
Experimental: McGRATH
|
Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy
Other Names:
Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
Other Names:
|
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.
Sponsor
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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