Self-pressurised Air-Q With Blocker Versus Baska Mask in Low Risk Female Patients Undergoing Ambulatory Surgery.

Supraglottic Airway Devices Clinical Trial

Official title:

A Randomized Comparison of Self-pressurized Air-Q With Blocker With Baska Mask Supraglottic Airway in Low Risk Female Patients Undergoing Ambulatory Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03798392
• Other study ID #: N-24- 2018
• Status: Recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: June 2019

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: Abeer Ahmed, MD
• Phone: 01005244590
• Email: abeer_ahmed[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.

Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker has a communication orifice at the junction of the peri-glotic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation.

The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.

To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inflatable cuff.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female patients between the age group of 18 and 50 years,

• ASA class I and II,

• undergoing elective surgeries,

• with Ganzouri airway score less than 4

Exclusion Criteria:

• ASA III - V patients.

• Airway score = 4 according to El-Ganzouri Airway Scoring System.

• Patients with respiratory or pharyngeal pathology.

• Patients allergic to any drugs in the protocol.

• Obese patients with body mass index = 40.

• Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery.

Related Conditions & MeSH terms

• Supraglottic Airway Devices

Intervention

Device:
• Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
comparing the airway seal pressure 10 min after insertion of each devices .
• Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
comparing the airway seal pressure 10 min after insertion of each devices .

Locations

Country	Name	City	State
Egypt	Kasr Alainy Faculty of Medicine - Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	airway seal pressure 10 minutes after insertion		10 minutes after the device insertion.