Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation

November 1, 2022 updated by: Hoda Zakaria Saleh Hassan Alrify, Cairo University

Air Q Intubating Laryngeal Airway (Air QILA) Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation Assisted by Tube Exchanger, a Randomized Comparative Study.

The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA .

the hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.

Study Type

Interventional

Enrollment (Anticipated)

44

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 Contact

Study Locations

  • Egypt
    • Elmanial
      • Cairo, Elmanial, Egypt, 11559
        • Kasr Alainy Hospital

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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : 18 to 60
  • ASA physical status 1 and 2
  • body weight less than 90 kilos
  • Ganzouri airway score less than or equal to 3.

Exclusion Criteria:

  • Active respiratory or cardiac disease
  • Any expected airway difficulties
  • Craniofacial abnormalities or fractures
  • patients with abnormal coagulation profile

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Air Q ILA group
Air Q supraglottic device will be placed in the participants in this group .
Device: cook ®Airway Exchanger Catheter
A tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device.
Experimental: Ambu AuraGain group
Ambu AuraGain supraglottic device will be placed in the participants in this group .
Device: cook ®Airway Exchanger Catheter
A tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total endotracheal intubation time
Time Frame: time of tube exchanger insertion and endotracheal tube insertion
tube exchanger intubation time plus endotracheal intubation time
time of tube exchanger insertion and endotracheal tube insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of endotracheal intubation
Time Frame: 1 second after insertion tube exchanger until successful endotracheal intubation
incidence of successful endotracheal intubation
1 second after insertion tube exchanger until successful endotracheal intubation
Tube exchanger insertion time
Time Frame: from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea
time from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea
from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative hoarseness of voice
Time Frame: 2 hours postoperative
change of voice
2 hours postoperative

Collaborators and Investigators

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

Sponsor

Cairo 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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • supraglottic devices

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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