VentilationBASKAMASKNCT03287752
BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery
An observational study of Ventilation, run by Assiut University at 1 site in Egypt.
Trial summary
The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. These include; A non-inflatable cuff, that it is continuous with the central channel of the device. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Ventilation
- What is being tested?
- BASKA MASK and Endotracheal tube
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2017to 29 Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult
Study population: Female patients scheduled for elective gynecological laparoscopic surgery.
Who may be able to join
- Sex: Female patients scheduled for elective gynecological laparoscopic surgery.
- Age: 18-60 years.
- BMI< 30kg/m2.
- ASA physical status: I-II.
- Operation: gynecological laparoscopic surgery under general anesthesia of an anticipated duration<1h.
Who cannot join
- Patient refusal.
- History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
- Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
- Neck pathology.
- Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance < 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance < 65 mm).
- Allergy to any of the anesthetic agents used.
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- The possibility of being pregnant.
- Heavy smoker.
- Preoperative sore throat.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
women health hospital, Assiut university
Asyut, Assiut Governorate, 715715
About this study
Official title: A Prospective Randomized Comparison of the Effect of BASKA Mask Versus Endo Tracheal Tube on Respiratory Function Parameters in Patients Undergoing Gynecological Laparoscopic Surgery
The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient.
Read the detailed description
The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area.
Compared with previous versions, these modifications have made BASKA mask airway a fairly safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic surgeries
- Conditions
- Ventilation
- Being tested
- BASKA MASK, Endotracheal tube
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASKA MASKDevice
Also called BASKA
Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant
Endotracheal tubeDevice
Also called ETT
Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| BASKA MASK | Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant. Receives: Device: BASKA MASK | |
| Endotracheal tube | Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT. Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
Peak airway pressure before and after abdominal inflation.
Measured: 6 hours including preoperative, intraoperative and 4h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start14 Sep 2017
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdelghaffar, MD, Principal investigator, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287752
- Sponsor's protocol ID
- 17100178
- Acronym
- BASKAMASK
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2017
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of the Effect of BASKA Mask Versus Endo Tracheal Tube on Respiratory Function Parameters in Patients Undergoing Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03287752
- Acronym / sponsor ID
- BASKAMASK / 17100178
- Conditions
- Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 19 Sep 2017 (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 (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient.
Detailed description
The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area.
Compared with previous versions, these modifications have made BASKA mask airway a fairly safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic surgeries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASKA MASK | – | Device: BASKA MASKPatients will be anesthetized using BASKA mask after lubrication with water soluble lubricant. |
| Endotracheal tube | – | Device: Endotracheal tubePatients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients scheduled for elective gynecological laparoscopic surgery.
Key inclusion criteria (5 listed)
- Sex: Female patients scheduled for elective gynecological laparoscopic surgery.
- Age: 18-60 years.
- BMI< 30kg/m2.
- ASA physical status: I-II.
- Operation: gynecological laparoscopic surgery under general anesthesia of an anticipated duration<1h.
Key exclusion criteria (9 listed)
- Patient refusal.
- History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
- Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
- Neck pathology.
- Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance < 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance < 65 mm).
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 |
|---|---|---|
| BASKA MASKAlso: BASKAPatients will be anesthetized using BASKA mask after lubrication with water soluble lubricant | Device | BASKA MASK |
| Endotracheal tubeAlso: ETTPatients will be anesthetized using appropriate sized cuffed oral endotracheal tube. | Device | Endotracheal tube |
Primary outcome
Peak airway pressure
Time frame: 6 hours including preoperative, intraoperative and 4h after operation
Peak airway pressure before and after abdominal inflation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Hala S Abdelghaffar, MD principal investigator
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation, run by Assiut 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak airway pressure (time frame: 6 hours including preoperative, intraoperative and 4h after operation). 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 18 Oct 2021.