Supraglottic Airway DevicesNCT03798392
Self-pressurised Air-Q With Blocker Versus Baska Mask in Low Risk Female Patients Undergoing Ambulatory Surgery.
A study testing Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion and Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion in people with Supraglottic Airway Devices, run by Cairo University at 1 site in Egypt.
Trial summary
Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Supraglottic Airway Devices
- What is being tested?
- Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion and Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2019to Jun 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients between the age group of 18 and 50 years,
- ASA class I and II,
- undergoing elective surgeries,
- with Ganzouri airway score less than 4
Who cannot join
- ASA III - V patients.
- Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
- Patients with respiratory or pharyngeal pathology.
- Patients allergic to any drugs in the protocol.
- Obese patients with body mass index ≥ 40.
- Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy Faculty of Medicine - Cairo university
Cairo, 00225
Abeer Ahmed, Assistant Professor
About this study
Official title: A Randomized Comparison of Self-pressurized Air-Q With Blocker With Baska Mask Supraglottic Airway in Low Risk Female Patients Undergoing Ambulatory Surgery.
Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.
Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker has a communication orifice at the junction of the peri-glotic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation.
Read more
The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.
To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inflatable cuff.
- Conditions
- Supraglottic Airway Devices
- Being tested
- Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion, Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertionDevice
Also called airway management under general anesthesia
comparing the airway seal pressure 10 min after insertion of each devices .
Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertionDevice
Also called airway management under general anesthesia
comparing the airway seal pressure 10 min after insertion of each devices .
| Study group | Role | What they receive |
|---|---|---|
| SP group | Active comparator | Not described Receives: Device: Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion |
| Baska group | Active comparator | Not described Receives: Device: Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway seal pressure 10 minutes after insertion
Measured: 10 minutes after the device insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airway DevicesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798392
- Sponsor's protocol ID
- N-24- 2018
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Self-pressurized Air-Q With Blocker With Baska Mask Supraglottic Airway in Low Risk Female Patients Undergoing Ambulatory Surgery.
- ClinicalTrials.gov ID
- NCT03798392
- Acronym / sponsor ID
- N-24- 2018
- Conditions
- Supraglottic Airway Devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 10 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.
Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.
Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker has a communication orifice at the junction of the peri-glotic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation.
The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.
To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inflatable cuff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP group | Active comparator | Device: Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion |
| Baska group | Active comparator | Device: Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients between the age group of 18 and 50 years,
- ASA class I and II,
- undergoing elective surgeries,
- with Ganzouri airway score less than 4
Key exclusion criteria (6 listed)
- ASA III - V patients.
- Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
- Patients with respiratory or pharyngeal pathology.
- Patients allergic to any drugs in the protocol.
- Obese patients with body mass index ≥ 40.
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 |
|---|---|---|
| Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertionAlso: airway management under general anesthesiacomparing the airway seal pressure 10 min after insertion of each devices . | Device | SP group |
| Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertionAlso: airway management under general anesthesiacomparing the airway seal pressure 10 min after insertion of each devices . | Device | Baska group |
Primary outcome
airway seal pressure 10 minutes after insertion
Time frame: 10 minutes after the device insertion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion and Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion in people with Supraglottic Airway Devices, 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 6 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 10 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer Ahmed, MD (01005244590, abeer_ahmed@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway seal pressure 10 minutes after insertion (time frame: 10 minutes after the device insertion.). 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 10 Jan 2019.