Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA

February 2, 2017 updated by: Zehra Ipek ARSLAN, Kocaeli University
bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.

Divided into two groups ; Airtraq and ILMA .

BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this study.

patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade.

The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Turkey
      • Kocaeli, Turkey, 41900
        • Kocaeli University School of Medicine

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:18-65 years of age

  • ASA I-III
  • BMI>35

Exclusion Criteria:BMI<35

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

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: intubation time
handling the device till the endotracheal tube passing through the glottis
Device: Airtraq
video laryngoscope with a channel
Device: ILMA
Other Names:
  • intubating laryngeal mask airway
ACTIVE_COMPARATOR: insertion time
handling of the device till the glottic visualization
Device: Airtraq
video laryngoscope with a channel
Device: ILMA
Other Names:
  • intubating laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation time
Time Frame: 1 minute
handling of the device till the endotracheal tube entering the glottis
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

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)

June 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (ESTIMATE)

November 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOU KAEK 2014/137

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.

Clinical Trials on Intubation Complication

Clinical Trials on Airtraq

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe