Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask

December 17, 2019 updated by: Bassant M. Abdelhamid, Cairo University

Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.

Supraglottic airway devices are important tools for airway management. Supraglottic airway devices have been introduced into brief surgical interventions because they are less invasive than intubation and safer than mask to maintain the patency of airway after induction of anesthesia. They are inserted via the oral route and can be used in emergency conditions when tracheal intubation and mask anesthesia are challenging.

Air Q intubating airway and Ambu Aura intubating laryngeal mask are two Supraglottic airway devices that are widely used.

Aim of the work is to compare Air-Q intubating laryngeal airway versus Ambu-Aura intubating laryngeal mask regarding sealing pressure and Fiberoptic intubation in class II obese patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized comparative trial that will be performed in Kasr Al Ainy hospital, Cairo University, Cairo, Egypt.ASA II patients from 20 to 50 years of age, undergoing minor surgry were included in this study. 40 patients will be allocated into 2 equal groups using computerized software and enclosed in sealed opaque envelopes:

GQ ( n=20 ): Where Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.

GA ( n=20 ): Where Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.

Study Type

Interventional

Enrollment (Anticipated)

40

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

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-65 years old.
  • Sex: both genders.
  • With American society of anaesthesiologists (ASA) physical activity II.
  • Scheduled for elective surgery under general anaesthesia requiring endotracheal tube.
  • Class II obese patients (BMI 34.9 - 39.9 kg/m2).
  • Surgery: short time procedures ≥ 60 minutes, ≤ 120 minutes e.g.: breast surgery, elbow or foot surgery.

Exclusion Criteria:

  • • Patient refusal.

    • Patients with any respiratory tract abnormalities as laryngeal masses & facial deformities as fracture mandible.
    • Patients with risk of pulmonary aspiration as in full stomach patients.
    • Patients at risk of regurgitation of gastric content as in gastroesophageal reflux disease (GERD) and pregnant females.
    • Emergency operation.
    • Patients with obstructive sleep apnea.
    • Patients prepared for laparotomy or laparoscopic procedures.
    • Patients with risk of bleeding.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Air-Q intubating laryngeal airway mask

Where Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.

After complete muscle relaxation a suitable sized (according to the patient's weight and BMI) Air-Q will be lubricated inserted and the ventilator circuit will be connected to the device to ventilate the patient. The ventilator will be set with tidal volume 4-6 ml/kg at a respiratory rate 12-15 breath/minute to keep normocapnia (ETCO2=30-35 mmHg). Vitals (HR, ABP and O2 saturation) and ET CO2were recorded 5 minutes after device insertion.

Then intubation using the fiberoptic bronchoscope will be started through the supraglottic device, laryngeal view grade will be recorded, success of endotracheal intubation through the device and time of intubation (time starting from disconnection of the circuit from the device to use the fiberoptic brochoscope for intubation till tube insertion in the trachea).
Device: Air-Q intubating laryngeal airway
Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.
Experimental: Ambu-Aura intubating laryngeal mask

Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.

After complete muscle relaxation a suitable sized (according to the patient's weight and BMI) Ambu-Aura laryngeal mask will be lubricated inserted and the ventilator circuit will be connected to the device to ventilate the patient. The ventilator will be set with tidal volume 4-6 ml/kg at a respiratory rate 12-15 breath/minute to keep normocapnia (ETCO2=30-35 mmHg). Vitals (HR, ABP and O2 saturation) and ET CO2 will be recorded 5 minutes after device insertion.

Then intubation using the fiberoptic bronchoscope will be started through the supraglottic device, laryngeal view grade will be recorded, success of endotracheal intubation through the device and time of intubation (time starting from disconnection of the circuit from the device to use the fiberoptic brochoscope for intubation till tube insertion in the trachea).
Device: Ambu-Aura intubating laryngeal mask
Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
airway seal pressure
Time Frame: 1 minute
Measuring the seal pressure above which the oropharyngeal leak through the supraglottic device will occur (1 minute after confirmation of successful insertion).
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 1 minute
Success rate of device insertion
1 minute
arterial blood pressure
Time Frame: 2 hours
systolic and diastolic arterial blood pressure. • Stress response related to the device used.
2 hours
heart rate
Time Frame: 2 hours
• Stress response related to the device used
2 hours
Laryngeal view grade.
Time Frame: 1 minute

Grade 1: only larynx was seen, Grade 2: larynx plus the posterior surface of epiglottis were seen. Grade 3: larynx and anterior tip of epiglottis were seen with <50% visual obstruction of larynx.

Grade 4: epiglottis down folded and its anterior surface were seen with >50% visual field obstruction.

Grade 5: complete down folding of epiglottis and the larynx could not be seen directly
1 minute
Success rate of intubation by fiberoptic bronchoscope
Time Frame: 1 minute
The success of the ventilation will be determined based on visible chest expansion, adequate tidal volume and drawing of 6 successive ETCO2 waves.
1 minute

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Bassant abdelhamid, 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 (Actual)

December 10, 2019

Primary Completion (Anticipated)

January 10, 2020

Study Completion (Anticipated)

January 15, 2020

Study Registration Dates

First Submitted

December 7, 2019

First Submitted That Met QC Criteria

December 7, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-19-2019

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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