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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05363566
Enrollment
78
Registered
2022-05-06
Start date
2021-06-30
Completion date
2023-11-30
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Baska Mask

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

Interventions

DEVICEairway divice

inserted airway device

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
insertion time1 hourTo 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

MeasureTime frameDescription
Ease of device insertion1 hourswill 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).
Oropharyngeal leak pressures1 hoursOropharyngeal leak pressures (OLPs) will be recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026