NCT04003727

Brief Summary

In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

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

June 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

June 28, 2019

Last Update Submit

June 16, 2020

Conditions

Intubation

Outcome Measures

Primary Outcomes (2)

  • Glottic view

    the percentage of glottic opening (POGO) and cormack-lehane scores will be used to rate of the glottic view

    During laryngoscopy

  • Intubation Success

    Intubation attempt number will be recorded

    During intubation

Secondary Outcomes (2)

  • Intubation difficulty

    During Laryngoscopy

  • Intubation time

    During Intubation

Study Arms (3)

Neutral Position

ACTIVE COMPARATOR

Head and neck will be on neutral position.

Device: Mcgrath Mac Videolaryngoscope

Sniffing Position

ACTIVE COMPARATOR

Head and neck will be on sniffing position

Device: Mcgrath Mac Videolaryngoscope

Head Extension position

ACTIVE COMPARATOR

Head will be on simple extension position

Device: Mcgrath Mac Videolaryngoscope

Interventions

Mcgrath Mac VideolaryngoscopeDEVICE

Patient's laryngoscopy will be done using McGrath Mac video laryngoscope

Head Extension positionNeutral PositionSniffing Position

Eligibility Criteria

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

You may qualify if:

  • Being 18-65 aged
  • Being obese
  • Undergoing surgery under general anesthesia

You may not qualify if:

  • Having difficult airway
  • Being American Society of Anesthesiologist (ASA) 4 physical status
  • Undergoing emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Hospital

Tokat Province, Merkez, 60100, Turkey (Türkiye)

Location

Study Officials

  • Tugba Karaman, MD

    Tokat Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 1, 2019

Study Start

July 10, 2019

Primary Completion

March 10, 2020

Study Completion

March 12, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

TU(1)