Baska MaskNCT03812081
A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure
A study testing Group A : Baska Mask Airway and Group B: Proseal Laryngeal Mask Airway in people with Baska Mask, run by Cairo University at 1 site in Egypt.
Trial summary
Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA) regarding performance of Baska mask improves the safety and efficacy of airway management for in patients undergoing general anesthesia by mechanical ventilation confirmation of position by fiber optic view of glottis opening and… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Baska Mask
- What is being tested?
- Group A : Baska Mask Airway and Group B: Proseal Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2018to 7 Feb 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult ASA I-II patients,
- Both genders, aged 18-45 years,
- Body weight between 50 and 90 kg who BMI > 30 kg/m2
- Non-urgent surgery of planned duration up to 2 hrs
Who cannot join
- Patient refusal
- Patients having known tendency to nausea/vomiting or pharyngeal pathology
- Morbid obese patients with body mass index >30 kg/m2
- Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery
- History of difficult intubation, measured the common predictive indices for difficult intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance, dentition and neck movement ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure According to Confirmation by Fiberoptic Position
Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA) regarding performance of Baska mask improves the safety and efficacy of airway management for in patients undergoing general anesthesia by mechanical ventilation confirmation of position by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing pressure, Leak fraction, insertion time and "overall insertion" success rates, and post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).
Read the detailed description
Maintenance of a patent airway is a major responsibility for the anesthesiologists, interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes such as brain damage or death.
Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask airway, many other supraglottic devices have been introduced in the clinical practice of airway management, trying to offer a simple and effective alternative to endotracheal tube.
However, following experience with such simple cases, clinicians soon become comfortable with more complex cases, such as cases of longer duration, cases with sicker patient reported favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost analyses. However, there is an under reporting of complications aris¬ing during ventilation with this device and the risk factors associated with such complications in adult patients. These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation, bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT. These can be significantly serious and life threatening
- Conditions
- Baska Mask
- Being tested
- Group A : Baska Mask Airway, Group B: Proseal Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A : Baska Mask AirwayDevice
Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers
Group B: Proseal Laryngeal Mask AirwayDevice
Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Group A Baska Mask | Active comparator | In which Baska Mask Airway (size 3,4,5) will used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers Receives: Device: Group A : Baska Mask Airway |
| Group B Proseal Mask | Active comparator | In which Laryngeal Mask Airway- Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. Receives: Device: Group B: Proseal Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway sealing pressure in cmH2O
The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure.
A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure
Measured: 15 Minutes
Secondary outcomes (2)
Laryngeal view grades recorded by fiberoptic bronchoscopes.
fiberoptic bronchoscopes can record Laryngeal view grades
Measured: 15 Minutes
Device Complications:
Patients will be monitoring for the following complications: arterial oxygen desaturation, lip damage; blood staining on mask removal and laryngospasm, the incidence and severity of throat pain, dysphagia, Heart burn, Nausea and Vomiting at arrival and discharge from the recovery unit and on the first postoperative day
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start5 Dec 2018
- Primary completion5 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following approval from EL Kasr Al-Ainy teaching hospital ethical committee and an informed patient consent, the investigators enrolled 74adult patients ASA I and II, non-obese (BMI\<30) ranging from18-45 yrs. of age, Patients underwent a variety of elective surgical procedures in the supine position with SAD placement for ≤ 2 hours duration. Patients randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway \_ (size 3,4,5) will used for ventilation according of patient body weight. Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA\_ (size 3,4,5) was used for ventilation according of patient body weight.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812081
- Sponsor's protocol ID
- N_50_2018
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Press
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure According to Confirmation by Fiberoptic Position
- ClinicalTrials.gov ID
- NCT03812081
- Acronym / sponsor ID
- N_50_2018
- Conditions
- Baska Mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 22 Jan 2019 (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.
Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA) regarding performance of Baska mask improves the safety and efficacy of airway management for in patients undergoing general anesthesia by mechanical ventilation confirmation of position by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing pressure, Leak fraction, insertion time and "overall insertion" success rates, and post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).
Detailed description
Maintenance of a patent airway is a major responsibility for the anesthesiologists, interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes such as brain damage or death.
Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask airway, many other supraglottic devices have been introduced in the clinical practice of airway management, trying to offer a simple and effective alternative to endotracheal tube.
However, following experience with such simple cases, clinicians soon become comfortable with more complex cases, such as cases of longer duration, cases with sicker patient reported favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost analyses. However, there is an under reporting of complications aris¬ing during ventilation with this device and the risk factors associated with such complications in adult patients. These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation, bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT. These can be significantly serious and life threatening
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Following approval from EL Kasr Al-Ainy teaching hospital ethical committee and an informed patient consent, the investigators enrolled 74adult patients ASA I and II, non-obese (BMI<30) ranging from18-45 yrs. of age, Patients underwent a variety of elective surgical procedures in the supine position with SAD placement for ≤ 2 hours duration. Patients randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway _ (size 3,4,5) will used for ventilation according of patient body weight. Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA_ (size 3,4,5) was used for ventilation according of patient body weight.
| Arm | Type | Receives |
|---|---|---|
| Group A Baska Mask | Active comparator | Device: Group A : Baska Mask AirwayIn which Baska Mask Airway (size 3,4,5) will used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers |
| Group B Proseal Mask | Active comparator | Device: Group B: Proseal Laryngeal Mask AirwayIn which Laryngeal Mask Airway- Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult ASA I-II patients,
- Both genders, aged 18-45 years,
- Body weight between 50 and 90 kg who BMI > 30 kg/m2
- Non-urgent surgery of planned duration up to 2 hrs
Key exclusion criteria (5 listed)
- Patient refusal
- Patients having known tendency to nausea/vomiting or pharyngeal pathology
- Morbid obese patients with body mass index >30 kg/m2
- Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery
- History of difficult intubation, measured the common predictive indices for difficult intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance, dentition and neck movement ).
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 |
|---|---|---|
| Group A : Baska Mask AirwaySize selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers | Device | Group A Baska Mask |
| Group B: Proseal Laryngeal Mask AirwayProseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. | Device | Group B Proseal Mask |
Primary outcome
Airway sealing pressure in cmH2O
Time frame: 15 Minutes
The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure. A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure
2 secondary outcomes
Laryngeal view grades recorded by fiberoptic bronchoscopes.
Time frame: 15 Minutes
Device Complications:
Time frame: Through study completion
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 20 Feb 2019.
- Individual participant dataSharing planned: Undecided. Till Press
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 Group A : Baska Mask Airway and Group B: Proseal Laryngeal Mask Airway in people with 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 4 inclusion and 5 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 20 Feb 2019. 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?
Airway sealing pressure in cmH2O (time frame: 15 Minutes). 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 20 Feb 2019.