Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i

The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement

Study Overview

• Status: Enrolling by invitation
• Conditions: The Baska Mask
• Intervention / Treatment: Device: airway divice

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• Inclusion criteria

  1. Adult patients from 18 to 60 years of age.
  2. American Society of Anesthesiologists (ASA) physical status I and II
  3. Both genders
  4. Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.
  5. El Ganzouri index Score ≥ 4
  6. Patients with BMI < 35 kg/m2

• Exclusion criteria

  1. The patients who will be refusal or inability to give informed consent,
  2. ASA class III or IV
  3. El Ganzouri index Score < 4,
  4. Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology
  5. Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery
  6. Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h
  7. Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)
  8. Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: group I; will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK)	Device: airway divice; inserted airway device
ACTIVE_COMPARATOR: group II; will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK)	Device: airway divice; inserted airway device
ACTIVE_COMPARATOR: group III (SP Air-Q) (n = 26); will be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA)	Device: airway divice; inserted airway device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time	To determine the time taken for insertion of the device. (It will be calculated from the time of the mask will be taken away from the patient's face till the moment of the appearance of square wave capnography upstroke with the presence of sufficient ventilation) (second )	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of device insertion	will be graded using a five-point scoring system (4 = insertion at first attempt without tactile resistance, 3 = insertion at first attempt with little tactile resistance, 2 = insertion at first attempt with significant tactile resistance, 1 = insertion successful at second/third attempt, 0 = insertion failed at three attempts).	1 hours
Oropharyngeal leak pressures	Oropharyngeal leak pressures (OLPs) will be recorded	1 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2021
• Primary Completion (ANTICIPATED): November 13, 2023
• Study Completion (ANTICIPATED): November 30, 2023

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (ACTUAL): May 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: N-49-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: still working

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No