Blockbuster LMANCT06395922
Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy
A study testing Blockbuster LMA and Baska Mask in people with Blockbuster LMA and Baska Mask, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the performance and safety profiles of two supraglottic airway devices (SADs), the Blockbuster laryngeal mask airway (LMA) and the Baska Mask (BM), in patients underwent laparoscopic cholecystectomy (LC). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Blockbuster LMA, Baska Mask, Laparoscopic Cholecystectomy
- What is being tested?
- Blockbuster LMA and Baska Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Feb 2024to 1 Jun 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective LC under general anesthesia.
Who cannot join
- Anticipated difficult airway.
- Renal dysfunction.
- Hiatus hernia.
- Obesity.
- Pregnancy.
- Patients taking rate-controlling medications, steroids, opioids, or regular antacids.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Rabab M Mohamed, MD, 00201069122935, rabmoh_30@outlook.com
Atia G Anwar, MD
About this study
Official title: Blockbuster LMA Versus Baska Mask in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial
This study aimed to compare the performance and safety profiles of two supraglottic airway devices (SADs), the Blockbuster laryngeal mask airway (LMA) and the Baska Mask (BM), in patients underwent laparoscopic cholecystectomy (LC).
Read the detailed description
Laparoscopic surgery has become increasingly prevalent across numerous surgical disciplines due to the well-established benefits it offers over traditional open procedures. Laparoscopic cholecystectomy (LC), the surgical removal of the gallbladder, stands out as one of the most frequently performed laparoscopic operations worldwide.
Supraglottic airway devices (SADs) play a crucial role in airway management algorithms, serving as viable alternatives in both anticipated and unanticipated difficult airway situations.
The laryngeal mask airway (LMA) can be utilized to establish a routine airway during general anesthesia or, less frequently, as a conduit for tracheal intubation. Newer, improved LMA designs incorporate cuffs that provide higher sealing pressures than classic LMAs, while also allowing for the venting of gastric contents through a dedicated drain tube.
The Baska Mask (BM), a second-generation SAD, features a non-inflatable cuff that is continuous with the airway channel, thereby inflating with positive pressure ventilation to improve cuff seal.
- Conditions
- Blockbuster LMA, Baska Mask, Laparoscopic Cholecystectomy
- Being tested
- Blockbuster LMA, Baska Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blockbuster LMADevice
The LMA was inserted using the recommended technique, with the patient's head in the sniffing position. The appropriate size was selected based on body weight (size 3 for 30-50 kg, size 4 for 50-70 kg)
Baska MaskDevice
The BM was inserted by opening the mouth, avoiding the tongue, and negotiating the palatopharyngeal curve using the hand-tab.
| Study group | Role | What they receive |
|---|---|---|
| Blockbuster LMA (Group BL) | Experimental | The LMA was inserted using the recommended technique, with the patient's head in the sniffing position. The appropriate size was selected based on body weight (size 3 for 30-50 kg, size 4 for 50-70 kg). Receives: Device: Blockbuster LMA |
| Baska Mask (Group BM) | Experimental | The BM was inserted by opening the mouth, avoiding the tongue, and negotiating the palatopharyngeal curve using the hand-tab. Receives: Device: Baska Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Oropharyngeal leak pressure was measured Just after insertion and 30 min after insertion.
Measured: 30 min after insertion
Secondary outcomes (3)
Device insertion time
The time from start of insertion till successful insertion.
Measured: 5 min after insertion
The incidence of successful gastric tube placement
The incidence of successful gastric tube placement through the device.
Measured: 10 min after insertion
Complications
Complications such as including pain in the throat, difficulty in swallowing, cough, and blood on the device were measured.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start6 Feb 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blockbuster LMAStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Mohamed Mohamed Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395922
- Sponsor's protocol ID
- 36264PR526/2/24
- Status last verified
- May 2024
- First submitted
- 27 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blockbuster LMA Versus Baska Mask in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06395922
- Acronym / sponsor ID
- 36264PR526/2/24
- Conditions
- Blockbuster LMA, Baska Mask, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 2 May 2024 (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.
This study aimed to compare the performance and safety profiles of two supraglottic airway devices (SADs), the Blockbuster laryngeal mask airway (LMA) and the Baska Mask (BM), in patients underwent laparoscopic cholecystectomy (LC).
Detailed description
Laparoscopic surgery has become increasingly prevalent across numerous surgical disciplines due to the well-established benefits it offers over traditional open procedures. Laparoscopic cholecystectomy (LC), the surgical removal of the gallbladder, stands out as one of the most frequently performed laparoscopic operations worldwide.
Supraglottic airway devices (SADs) play a crucial role in airway management algorithms, serving as viable alternatives in both anticipated and unanticipated difficult airway situations.
The laryngeal mask airway (LMA) can be utilized to establish a routine airway during general anesthesia or, less frequently, as a conduit for tracheal intubation. Newer, improved LMA designs incorporate cuffs that provide higher sealing pressures than classic LMAs, while also allowing for the venting of gastric contents through a dedicated drain tube.
The Baska Mask (BM), a second-generation SAD, features a non-inflatable cuff that is continuous with the airway channel, thereby inflating with positive pressure ventilation to improve cuff seal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blockbuster LMA (Group BL) | Experimental | Device: Blockbuster LMAThe LMA was inserted using the recommended technique, with the patient's head in the sniffing position. The appropriate size was selected based on body weight (size 3 for 30-50 kg, size 4 for 50-70 kg). |
| Baska Mask (Group BM) | Experimental | Device: Baska MaskThe BM was inserted by opening the mouth, avoiding the tongue, and negotiating the palatopharyngeal curve using the hand-tab. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective LC under general anesthesia.
Key exclusion criteria (6 listed)
- Anticipated difficult airway.
- Renal dysfunction.
- Hiatus hernia.
- Obesity.
- Pregnancy.
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 |
|---|---|---|
| Blockbuster LMAThe LMA was inserted using the recommended technique, with the patient's head in the sniffing position. The appropriate size was selected based on body weight (size 3 for 30-50 kg, size 4 for 50-70 kg) | Device | Blockbuster LMA (Group BL) |
| Baska MaskThe BM was inserted by opening the mouth, avoiding the tongue, and negotiating the palatopharyngeal curve using the hand-tab. | Device | Baska Mask (Group BM) |
Primary outcome
Oropharyngeal leak pressure
Time frame: 30 min after insertion
Oropharyngeal leak pressure was measured Just after insertion and 30 min after insertion.
3 secondary outcomes
Device insertion time
Time frame: 5 min after insertion
The incidence of successful gastric tube placement
Time frame: 10 min after insertion
Complications
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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 Blockbuster LMA and Baska Mask in people with Blockbuster LMA and Baska Mask, run by Tanta 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 2 May 2024. 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 Rabab M Mohamed, MD (00201069122935, rabmoh_30@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal leak pressure (time frame: 30 min after 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 2 May 2024.