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

Cairo University (CU)

Status: Unknown

Conditions: Airway Management; Obesity

Treatments: Device: Ambu-Aura intubating laryngeal mask; Device: Air-Q intubating laryngeal airway

Study type: Interventional

Funder types: Other

Identifiers

NCT04195035

S-19-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Air-Q intubating laryngeal airway mask

Experimental group

Description:

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).

Treatment:

Device: Air-Q intubating laryngeal airway

Ambu-Aura intubating laryngeal mask

Experimental group

Description:

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).

Treatment:

Device: Ambu-Aura intubating laryngeal mask