Supraglottic Airway DevicesNCT03542890
Respiration and The Airway With Laryngeal Masks
An observational study of Supraglottic Airway Devices, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
Trial summary
Baska® mask (Proact Medical Systems, Frenchs Forest NSW, Australia) is displayed in figure 1 which is the latest addition to an array of supra-glottic airway devices in clinical use. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Supraglottic Airway Devices
- What is being tested?
- Baska Mask and I-gel
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2018to 10 Aug 2021
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: adult female patients undergoing elective gynecological operations.
Who may be able to join
- Adult female patients ASA I\&II
- Age: 18- 45 years old
- BMI < 35
- Undergoing elective gynecological operations.
Who cannot join
- Patients with history of upper respiratory tract infections and obstructive sleep apnea.
- Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
- Patients with El-Ganzouri airway score ≥ 5 will.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562
About this study
Official title: Comparison Between Baska and I-gel in Controlled Mechanically Ventilated Females Undergoing Vaginal Surgeries
Baska® mask (Proact Medical Systems, Frenchs Forest NSW, Australia) is displayed in figure 1 which is the latest addition to an array of supra-glottic airway devices in clinical use. It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. However, the cuff differs from other non-inflatable cuffs in that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation ,the cuff itself is inflated which may improve the seal so reducing leak and make ventilation more efficient. The Baska mask has two ports (one for venting and other for gastric tube insertion ), so it incorporates an inlet that fits into the upper oesophagus 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. These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area. In addition, there is integrated bite-block, which reduces the risk of patients biting and blocking the airway. There is insertion tab which is an extended hand-tab attached to the cuff that permits the operator to control the degree of flexion of the device during the insertion. The Baska® mask is inserted in the neutral head position, which may reduce the need for neck manipulation. Initial experience with Baska®mask has demonstrated it to be a suitable airway device for procedures less than 2 hours or when endotracheal intubation is not required.
I-gel airway (Intersurgical Ltd, Workingham, Berkshire,United Kingdom) is displayed in figure 2 which is second generation supraglottic airway devices (SADs) that was introduced in 2007. The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. With an epiglottic rest and wider and shorter stem, the I-gel gives an optimal view of the glottis with a fiber- optic scope so a shorter tube is ideal for endotracheal tube placement. Moreover, I-gel can be inserted as fast as classic LMA (Laryngeal Mask Airway) with adequate ventilation in patients and has no major airway complications. Therefore, it could be a good alternative to classic LMA in emergency airway management or general anesthesia.
Read the detailed description
The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 60 adult female(18-55 years old, ASAI\&II) patients to a prospective randomized crossover clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea , potentially full stomach( trauma, morbid obesity BMI> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study.The patients will be randomly allocated into two groups(the Baska Mask group \& the I-gel group; each group is 30 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
- Conditions
- Supraglottic Airway Devices
- Being tested
- Baska Mask, I-gel
- Keywords
- Anesthesia, General, Baska, I-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baska MaskDevice
used in adult low risk females undergoing elective gynecological operations
I-gelDevice
used in adult low risk females undergoing elective gynecological operations
| Study group | Role | What they receive |
|---|---|---|
| Baska Mask | It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. Receives: Device: Baska Mask | |
| I-gel | The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. Receives: Device: I-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached while the patient was apneic, and following confirmation of adequate ventilation, the adjustable pressure limit valve was set at 70 cmH2O, the fresh gas flow was set at 6 l.min-1(liter per minute), and the airway pressure was measured on the breathing system pressure gauge. Leak pressure will be defined as the plateau airway pressure that was achieved
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start14 Jun 2018
- Primary completion8 Jul 2021
- Study completion10 Aug 2021
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.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Ali Abdelhaleem Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542890
- Sponsor's protocol ID
- BM2008
- Status last verified
- Sep 2021
- First submitted
- 17 Apr 2018
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Baska and I-gel in Controlled Mechanically Ventilated Females Undergoing Vaginal Surgeries
- ClinicalTrials.gov ID
- NCT03542890
- Acronym / sponsor ID
- BM2008
- Conditions
- Supraglottic Airway Devices
- Keywords
- Anesthesia, General, Baska, I-gel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Reham Ali Abdelhaleem AbdelrahmanUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 31 May 2018 (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 (Proact Medical Systems, Frenchs Forest NSW, Australia) is displayed in figure 1 which is the latest addition to an array of supra-glottic airway devices in clinical use. It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. However, the cuff differs from other non-inflatable cuffs in that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation ,the cuff itself is inflated which may improve the seal so reducing leak and make ventilation more efficient. The Baska mask has two ports (one for venting and other for gastric tube insertion ), so it incorporates an inlet that fits into the upper oesophagus 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. These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area. In addition, there is integrated bite-block, which reduces the risk of patients biting and blocking the airway. There is insertion tab which is an extended hand-tab attached to the cuff that permits the operator to control the degree of flexion of the device during the insertion. The Baska® mask is inserted in the neutral head position, which may reduce the need for neck manipulation. Initial experience with Baska®mask has demonstrated it to be a suitable airway device for procedures less than 2 hours or when endotracheal intubation is not required.
I-gel airway (Intersurgical Ltd, Workingham, Berkshire,United Kingdom) is displayed in figure 2 which is second generation supraglottic airway devices (SADs) that was introduced in 2007. The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. With an epiglottic rest and wider and shorter stem, the I-gel gives an optimal view of the glottis with a fiber- optic scope so a shorter tube is ideal for endotracheal tube placement. Moreover, I-gel can be inserted as fast as classic LMA (Laryngeal Mask Airway) with adequate ventilation in patients and has no major airway complications. Therefore, it could be a good alternative to classic LMA in emergency airway management or general anesthesia.
Detailed description
The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 60 adult female(18-55 years old, ASAI\&II) patients to a prospective randomized crossover clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea , potentially full stomach( trauma, morbid obesity BMI> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study.The patients will be randomly allocated into two groups(the Baska Mask group \& the I-gel group; each group is 30 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baska Mask | – | Device: Baska MaskIt has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. |
| I-gel | – | Device: I-gelThe I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult female patients undergoing elective gynecological operations.
Key inclusion criteria (4 listed)
- Adult female patients ASA I\&II
- Age: 18- 45 years old
- BMI < 35
- Undergoing elective gynecological operations.
Key exclusion criteria (3 listed)
- Patients with history of upper respiratory tract infections and obstructive sleep apnea.
- Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
- Patients with El-Ganzouri airway score ≥ 5 will.
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 Maskused in adult low risk females undergoing elective gynecological operations | Device | Baska Mask |
| I-gelused in adult low risk females undergoing elective gynecological operations | Device | I-gel |
Primary outcome
Oropharyngeal leak pressure
Time frame: one year
The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached while the patient was apneic, and following confirmation of adequate ventilation, the adjustable pressure limit valve was set at 70 cmH2O, the fresh gas flow was set at 6 l.min-1(liter per minute), and the airway pressure was measured on the breathing system pressure gauge. Leak pressure will be defined as the plateau airway pressure that was achieved
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 17 Sep 2021.
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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.
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?
An observational study of Supraglottic Airway Devices, run by Reham Ali Abdelhaleem Abdelrahman 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 3 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 17 Sep 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?
Oropharyngeal leak pressure (time frame: one year). 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 17 Sep 2021.