NCT02969889

Brief Summary

bmı \> 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

November 18, 2016

Last Update Submit

February 2, 2017

Conditions

Intubation; Difficult or FailedIntubation Complication

Keywords

AirtraqIntubating laryngeal mask airwayBMI>35

Outcome Measures

Primary Outcomes (1)

  • intubation time

    handling of the device till the endotracheal tube entering the glottis

    1 minute

Study Arms (2)

intubation time

ACTIVE COMPARATOR

handling the device till the endotracheal tube passing through the glottis

Device: AirtraqDevice: ILMA

insertion time

ACTIVE COMPARATOR

handling of the device till the glottic visualization

Device: AirtraqDevice: ILMA

Interventions

AirtraqDEVICE

video laryngoscope with a channel

insertion timeintubation time
ILMADEVICE
Also known as: intubating laryngeal mask airway
insertion timeintubation time

Eligibility Criteria

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

You may qualify if:

  • ASA I-III
  • BMI\>35

You may not qualify if:

  • patients have airway tumor
  • patients undergoing head and neck surgery
  • upper respiratory infection less than 10 days prior the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

Location

Study Officials

  • Zehra Arslan

    Kocaeli University Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 21, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

TU(1)