CClinicalTrials.gg
Status unknownNCT05363566Updated May 6, 2022

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

An interventional study of airway divice in The Baska Mask, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-06.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

02

Conditions studied

  • The Baska Mask
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In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adult patients from 18 to 60 years of age.

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

Exclusion criteria

  1. The patients who will be refusal or inability to give informed consent,

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Active comparator
    group I

    will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK)

    Device: airway divice

  • Active comparator
    group II

    will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK)

    Device: airway divice

  • 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

Interventions

  • Deviceairway divice

    inserted airway device

06

What researchers measure

Primary outcomes

  1. 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 )

    Time frame: 1 hour

Secondary outcomes

  1. 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).

    Time frame: 1 hours

  2. Oropharyngeal leak pressures

    Oropharyngeal leak pressures (OLPs) will be recorded

    Time frame: 1 hours

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Study locations

1 site
  • Cairo university
    Cairo, 11562, Egypt
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References and documents

Individual participant data

Plan to share: Undecided — still working

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05363566
Lead sponsor
Cairo University
Responsible party
Amr Samir Wahdan (Principal Investigator, Cairo University) — Principal investigator
First posted
May 6, 2022
Start date
Jun 30, 2021
Primary completion
Nov 13, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
May 6, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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