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

NCT ID: NCT04195035

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Airway Management Obesity

Keywords

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obesity Air QTM intubating airway Ambu-Aura intubating laryngeal mask

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

Air-Q intubating laryngeal airway

Intervention Type DEVICE

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

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).

Group Type EXPERIMENTAL

Ambu-Aura intubating laryngeal mask

Intervention Type DEVICE

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

Interventions

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Air-Q intubating laryngeal airway

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

Intervention Type DEVICE

Ambu-Aura intubating laryngeal mask

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Bassant M. Abdelhamid

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bassant abdelhamid

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Bassant abdelhamid

Role: CONTACT

Phone: 01224254012

Email: [email protected]

Inas Farouk

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bassant abdelhamid

Role: primary

References

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Kim MS, Lee JH, Han SW, Im YJ, Kang HJ, Lee JR. A randomized comparison of the i-gel with the self-pressurized air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2015 Apr;25(4):405-12. doi: 10.1111/pan.12609. Epub 2015 Jan 6.

Reference Type BACKGROUND
PMID: 25559870 (View on PubMed)

Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.

Reference Type BACKGROUND
PMID: 21081777 (View on PubMed)

Yahaya Z, Teoh WH, Dintan NA, Agrawal R. The AMBU(R) Aura-i Laryngeal Mask and LMA Supreme: A Randomized Trial of Clinical Performance and Fibreoptic Positioning in Unparalysed, Anaesthetised Patients by Novices. Anesthesiol Res Pract. 2016;2016:4717061. doi: 10.1155/2016/4717061. Epub 2016 Oct 25.

Reference Type BACKGROUND
PMID: 27847515 (View on PubMed)

Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.

Reference Type BACKGROUND
PMID: 21880031 (View on PubMed)

Other Identifiers

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S-19-2019

Identifier Type: -

Identifier Source: org_study_id