Clinical trial NCT04195035: Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask
Official title: Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Management
Obesity
Keywords: obesity
Air QTM intubating airway
Ambu-Aura intubating laryngeal mask
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: airway seal pressure
timeFrame: 1 minute
Secondary outcomes:
measure: Success rate
timeFrame: 1 minute
measure: arterial blood pressure
timeFrame: 2 hours
measure: heart rate
timeFrame: 2 hours
measure: Laryngeal view grade.
timeFrame: 1 minute
measure: Success rate of intubation by fiberoptic bronchoscope
timeFrame: 1 minute
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.