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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04195035
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
1.2
Anticipated Duration (Months)
33.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Air-Q intubating laryngeal airway
  • Device: Ambu-Aura intubating laryngeal mask
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.
Actual Study Start Date :
Dec 10, 2019
Anticipated Primary Completion Date :
Jan 10, 2020
Anticipated Study Completion Date :
Jan 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. airway seal pressure [1 minute]

    Measuring the seal pressure above which the oropharyngeal leak through the supraglottic device will occur (1 minute after confirmation of successful insertion).

Secondary Outcome Measures

  1. Success rate [1 minute]

    Success rate of device insertion

  2. arterial blood pressure [2 hours]

    systolic and diastolic arterial blood pressure. • Stress response related to the device used.

  3. heart rate [2 hours]

    • Stress response related to the device used

  4. Laryngeal view grade. [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

  5. Success rate of intubation by fiberoptic bronchoscope [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt 1772

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Bassant abdelhamid, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04195035
Other Study ID Numbers:
  • S-19-2019
First Posted:
Dec 11, 2019
Last Update Posted:
Dec 19, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bassant M. Abdelhamid, associate professor, Cairo University
obesity
Air QTM intubating airway
Ambu-Aura intubating laryngeal mask
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Dec 19, 2019