NCT03402581

Brief Summary

Obese patients may have difficulty in airway management.Patients who have body mass index \> 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

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

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

January 11, 2018

Last Update Submit

February 28, 2020

Conditions

Difficult Airway, Videolaryngoscopes

Outcome Measures

Primary Outcomes (1)

  • intubation difficulty

    the management of airway

    1 minute

Secondary Outcomes (1)

  • airway assesment

    1 minute

Study Arms (2)

c-mac used for intubation

obese patients intubated with c-mac videolaryngoscope

Device: c-mac laryngoscope

mc-grath used for intubation

obese patients intubated with mc-grath videolaryngoscope

Device: c-mac laryngoscope

Interventions

c-mac laryngoscopeDEVICE

type of laryngoscopes

Also known as: mc-grath laryngoscope
c-mac used for intubationmc-grath used for intubation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing elective surgery and have body mass index \> 35

You may qualify if:

  • body mass index\> 35

You may not qualify if:

  • emergency airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, 06550, Turkey (Türkiye)

Location

Study Officials

  • CIGDEM YILDIRIMGUCLU

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

September 2, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)