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

Obesity Clinical Trial

Official title:

Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195035
• Other study ID #: S-19-2019
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: Bassant abdelhamid
• Phone: 01224254012
• Email: bassantmohamed197[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 15, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management
• Obesity

Intervention

Device:
• Air-Q intubating laryngeal airway
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.

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q(®) 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. — View 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. — View 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. — View Citation

Yahaya Z, Teoh WH, Dintan NA, Agrawal R. The AMBU® 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. Epub 2016 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Success rate	Success rate of device insertion	1 minute
Secondary	arterial blood pressure	systolic and diastolic arterial blood pressure. • Stress response related to the device used.	2 hours
Secondary	heart rate	• Stress response related to the device used	2 hours
Secondary	Laryngeal view grade.	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	1 minute
Secondary	Success rate of intubation by fiberoptic bronchoscope	The success of the ventilation will be determined based on visible chest expansion, adequate tidal volume and drawing of 6 successive ETCO2 waves.	1 minute