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

NCT ID: NCT03798392

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2019-06-30

Brief 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.

Conditions

Supraglottic Airway Devices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

SP group

Group Type: ACTIVE_COMPARATOR

Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion

Intervention Type: DEVICE

comparing the airway seal pressure 10 min after insertion of each devices .

Baska group

Group Type: ACTIVE_COMPARATOR

Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion

Intervention Type: DEVICE

comparing the airway seal pressure 10 min after insertion of each devices .

Interventions

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 .

Intervention Type: DEVICE

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 .

Intervention Type: DEVICE

Other Intervention Names

airway management under general anesthesia; airway management under general anesthesia

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Ahmed, MD

Assistant Professor of Anesthesia, SICU and pain management - kasr Aiainy Faculty of Medicine - Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy Faculty of Medicine - Cairo university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abeer Ahmed, MD

Role: CONTACT

abeer_ahmed@kasralainy.edu.eg

01005244590

Facility Contacts

Abeer Ahmed, Assistant Professor

Role: primary

Other Identifiers

N-24- 2018

Identifier Type: -

Identifier Source: org_study_id