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

• Sponsor: Cairo University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05363566
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
The Baska Mask	Device: airway divice	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
• Actual Study Start Date: Jun 30, 2021
• Anticipated Primary Completion Date: Nov 13, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. insertion time [1 hour]

   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 )

Secondary Outcome Measures

1. Ease of device insertion [1 hours]

   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).

2. Oropharyngeal leak pressures [1 hours]

   Oropharyngeal leak pressures (OLPs) will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Cairo		Egypt	11562

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Samir Wahdan, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05363566
• Other Study ID Numbers: N-49-2021
• First Posted: May 6, 2022
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 6, 2022