Status:
UNKNOWN
Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
Lead Sponsor:
Cairo University
Conditions:
The Baska Mask
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Adult patients from 18 to 60 years of age.
- American Society of Anesthesiologists (ASA) physical status I and II
- Both genders
- Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.
- El Ganzouri index Score ≥ 4
- Patients with BMI \< 35 kg/m2
- Exclusion criteria
- The patients who will be refusal or inability to give informed consent,
- ASA class III or IV
- El Ganzouri index Score \< 4,
- Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology
- Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery
- Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h
- Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)
- Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.
Exclusion
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05363566
Start Date
June 30 2021
End Date
November 30 2023
Last Update
May 6 2022
Active Locations (1)
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1
Cairo university
Cairo, Egypt, 11562