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

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ClinicalTrials.gov Identifier: NCT03798392
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Abeer Ahmed, MD, Cairo University

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.


Condition or disease Intervention/treatment Phase
Supraglottic Airway Devices Device: Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion Device: Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: SP group 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 .
Other Name: airway management under general anesthesia

Active Comparator: Baska group 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 .
Other Name: airway management under general anesthesia




Primary Outcome Measures :
  1. airway seal pressure 10 minutes after insertion [ Time Frame: 10 minutes after the device insertion. ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798392


Contacts
Contact: Abeer Ahmed, MD 01005244590 abeer_ahmed@kasralainy.edu.eg

Locations
Egypt
Kasr Alainy Faculty of Medicine - Cairo university Recruiting
Cairo, Egypt, 00225
Contact: Abeer Ahmed, Assistant Professor         
Sponsors and Collaborators
Cairo University

Responsible Party: Abeer Ahmed, MD, Assistant Professor of Anesthesia, SICU and pain management - kasr Aiainy Faculty of Medicine - Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03798392     History of Changes
Other Study ID Numbers: N-24- 2018
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs