NCT04509453

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

August 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

July 27, 2020

Last Update Submit

December 14, 2020

Conditions

Intubation ComplicationIntubation;DifficultAnesthesia

Keywords

successful intubationclassic LMAvideo laryngoscopydifficultycuff pressure leak

Outcome Measures

Primary Outcomes (3)

  • Number of participants with first-attempt success

    Successful LMA insertion within first attempt

    immediately after LMA insertion

  • Mean arterial pressure

    Mean arterial pressure measured by non-invasive blood pressure monitor

    immediately after LMA insertion

  • Heart rate

    Heart rate measured by standard monitor

    immediately after LMA insertion

Secondary Outcomes (2)

  • Time required

    immediately after LMA insertion

  • Complications

    An hour after the the end of surgery

Study Arms (2)

McGRATH

EXPERIMENTAL
Device: McGRATH laryngoscopyDevice: Macintosh laryngoscopy

Macintosh

ACTIVE COMPARATOR
Device: McGRATH laryngoscopyDevice: Macintosh laryngoscopy

Interventions

McGRATH laryngoscopyDEVICE

Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy

Also known as: Group G
MacintoshMcGRATH
Macintosh laryngoscopyDEVICE

Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy

Also known as: Group I
MacintoshMcGRATH

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 12, 2020

Study Start

August 30, 2020

Primary Completion

October 30, 2020

Study Completion

November 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)