The Baska MaskNCT05363566
Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
A study testing airway divice in people with The Baska Mask, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- The Baska Mask
- What is being tested?
- airway divice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- The Baska Mask
- Being tested
- airway divice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway diviceDevice
inserted airway device
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK) Receives: Device: airway divice |
| group II | Active comparator | will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK) Receives: Device: airway divice |
| group III (SP Air-Q) (n = 26) | Active comparator | will be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA) Receives: Device: airway divice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 1 hour
Secondary outcomes (2)
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).
Measured: 1 hours
Oropharyngeal leak pressures
Oropharyngeal leak pressures (OLPs) will be recorded
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start30 Jun 2021
- Primary completion13 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Baska MaskStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363566
- Sponsor's protocol ID
- N-49-2021
- Status last verified
- May 2022
- First submitted
- 19 Mar 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
- ClinicalTrials.gov ID
- NCT05363566
- Acronym / sponsor ID
- N-49-2021
- Conditions
- The Baska Mask
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 13 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Device: airway divicewill be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK) |
| group II | Active comparator | Device: airway divicewill be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK) |
| group III (SP Air-Q) (n = 26) | Active comparator | Device: airway divicewill be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| airway diviceinserted airway device | Device | group I, group II, group III (SP Air-Q) (n = 26) |
Primary outcome
insertion time
Time frame: 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 )
2 secondary outcomes
Ease of device insertion
Time frame: 1 hours
Oropharyngeal leak pressures
Time frame: 1 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Undecided. still working
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing airway divice in people with The Baska Mask, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insertion time (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.