Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation

January 2, 2023 updated by: Heba Mohamed EL -Asser,MD, Zagazig University
To compare air Q versus ILMA intubation in obese adult paralyzed patient

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA regarding number and duration of attempts, laryngeal view grade, time to removal of device over tube without dislodgement and any complication

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

  • Egypt
      • Zagazig, Egypt, 002055
        • Zagazig University

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:All morbidly obese patient defined as BMI >40 kg/m2 scheduled for an elective surgery requiring general anesthesia with tracheal intubation were enrolled on the day of their surgery.

ASA physical status (I-II)

Exclusion Criteria physical status of IV or V or had a history of impossible tracheal intubation or awake fibreoptic intubation or if preoperative evaluation showed limited mouth aperture <3.5 cm or showed evidence that an awake fiberoptic intubation or rapid sequence induction would be required patients at increased risk for aspiration of gastric contents, coagulopathy or those with unstable cervical spines or requiring nasal route for tracheal intubation

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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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I ( Air Q)
nsertion of proper size Air-Q. ILA
Device: Air-Q. ILA insertion of proper size
Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device
Active Comparator: Group II (ILMA)
nsertion of proper size ILMA
Device: ILMA insertion of proper size
Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of tracheal intubation through each device.
Time Frame: Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices
success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time
Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion time of supraglottic airway devices
Time Frame: It is about 13-19 second for insertion of supraglottic airway devices
Time necessary for insertion was measured from the time the face mask was taken away until the appearance of Co2 on the capnograph while supraglottic airway device in place
It is about 13-19 second for insertion of supraglottic airway devices

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Study Chair: Khadiga M El Hossiney, MD, Zagazig University
  • Study Chair: Amani A Aly, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 20, 2019

Primary Completion (Actual)

June 20, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

June 28, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Intubation in morbid obese

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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