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

NCT04195035 | Unknown

• 1 other identifier: S-19-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management; Obesity

Keywords

obesity; Air QTM intubating airway; Ambu-Aura intubating laryngeal mask

Outcome Measures

Primary Outcomes (1)

• airway seal pressure

  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 Outcomes (5)

• Success rate

  1 minute

• arterial blood pressure

  2 hours

• heart rate

  2 hours

• Laryngeal view grade.

  1 minute

• Success rate of intubation by fiberoptic bronchoscope

  1 minute

Study Arms (2)

Air-Q intubating laryngeal airway mask

EXPERIMENTAL

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

Ambu-Aura intubating laryngeal mask

EXPERIMENTAL

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

Interventions

Air-Q intubating laryngeal airway DEVICE

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

Air-Q intubating laryngeal airway mask

Ambu-Aura intubating laryngeal mask DEVICE

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

Ambu-Aura intubating laryngeal mask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 1772, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 25559870 BACKGROUND

• 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.

  PMID: 21081777 BACKGROUND

• 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.

  PMID: 27847515 BACKGROUND

• 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.

  PMID: 21880031 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bassant abdelhamid

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bassant abdelhamid

CONTACT

01224254012; bassantmohamed197@yahoo.com

Inas Farouk

CONTACT

inasfarouk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 11, 2019
• Study Start: December 10, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 15, 2020
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)