Laparoscopic SurgeryNCT03045835
Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy
A study testing BASKA mask and Endotracheal intubation in people with Laparoscopic Surgery, run by University of Malaya at 1 site in Malaysia.
Trial summary
Baska mask is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- BASKA mask and Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2017to 31 Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old
- American Society of Anesthesiologists (ASA) physical status I and II BMI ≤ 35
- Laparoscopic cholecystectomy only
Who cannot join
- Known gastroesophageal reflux
- History of difficult intubation or difficult anaesthesia
- Features of facial, laryngeal and pharyngeal anatomy problem
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Petaling Jaya, Selangor, 59100
About this study
Official title: Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy : A Prospective Randomized Trial
Baska mask is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as well as reduce perioperative complications.
Read the detailed description
Patient's satisfaction and smooth process is crucial for perioperative care.Conduct of Anaesthesia including choice of airway devices play an important role. Endotracheal intubation has long been regarded as the technique of choice for airway management in laparoscopic surgery. However, there is currently an emerging interest in laryngeal mask as the substitute for endotracheal tube in laparoscopic surgery.
The increased abdominal pressure secondary to gas insufflation in Laparoscopic surgery demands a good supraglottic airway device with features of good seal, aspiration prevention and effective ventilation.
Few studies have evaluated the performance Baska® Mask for various type of surgery and had obtained high "first-attempt" success rate, easy insertion and a good oropharyngeal leak pressure above 30cmH2O with low complications such as sorethroat, dysphonia and dysphagia.
However, study regarding comparison of Baska® mask with endotracheal tube has not been carried out before. Therefore, the investigators would like to evaluate this novel device in comparison with endotracheal tube for laparoscopic surgery in our centre.
This will be a prospective randomized controlled study in University Malaya Medical Centre to compare Baska® mask with the conventional laryngoscope-guided endotracheal intubation for laparoscopic surgeries.
The investigators would like to study the efficacy of this device in term of : time to effective airway insertion, efficacy of airway seal, post-operation device of complications.
- Conditions
- Laparoscopic Surgery
- Being tested
- BASKA mask, Endotracheal intubation
- Keywords
- laparoscopic cholecystectomy BASKA mask Endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASKA maskDevice
Baska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth
Endotracheal intubationDevice
Endotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth
| Study group | Role | What they receive |
|---|---|---|
| BASKA mask | Experimental | Selection of size : size 3 (30-50kg), size 4 (50-70kg), size 5 (70-100kg) Receives: Device: BASKA mask |
| Endotracheal intubation | Active comparator | Selection of size : ID 7.0-7.5mm (women), ID 7.5-8.0mm (men) Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to effective airway insertion
defined as time from picking up the airway device (either BASKA mask or Endotracheal tube), insertion and until occurrence of the first square-waveform capnogram
Measured: 1 hour
Secondary outcomes (4)
Numbers of attempt of airway device insertion and Ease of insertion
defined as: 1 - first attempt easy, smooth insertion; 2 - second attempt, insertion with resistance; 3 - three attempts, insertion with difficulty; 4 -failed insertion of the SGAs and need to crossover to ETT group
Measured: 1 hour
Gastric distension scoring by surgeon
on a visual analogue scale 0-10 (Figure 2), where 0 = empty stomach, and 10 = heavy distension that interfered with surgical exposure at a) entry of the laparoscope following peritoneal insufflation and b) immediately before removal of the laparoscope at the end of the surgical procedure
Measured: during operative duration
Post operation incidence of complications
patients are assessed for the incidence of sore throat, airway trauma (lip, tongue, teeth, blood-staining on device), nausea, vomiting, airway spasm, aspiration, emergence cough
Measured: from the induction of anaesthesia, until at the postanaesthetic care unit (PACU), assessed up to 24 hours
Hemodynamic changes
Blood pressure and Heart rate
Measured: after induction of anaesthesia at 1, 2, 3,4,5,10,20,30 minutes; then post extubation at 1 ,2,3,4,5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion31 Aug 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ng Ching Choe, University of Malaya
- Investigators
- CHING CHOE NG, MMED(ANAES), Principal investigator, UNIVERSITY OF MALAYA MEDICAL CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045835
- Sponsor's protocol ID
- MREC ID NO: 201713-4728
- Status last verified
- Jul 2020
- First submitted
- 25 Jan 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng CC, Sybil Shah MHB, Chaw SH, Mansor MB, Tan WK, Koong JK, Wang CY. Baska mask versus endotracheal tube in laparoscopic cholecystectomy surgery: a prospective randomized trial. Expert Rev Med Devices. 2021 Feb;18(2):203-210. doi: 10.1080/17434440.2021.1865796. Epub 2020 Dec 31.
PubMed 33322949
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy : A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03045835
- Acronym / sponsor ID
- MREC ID NO: 201713-4728
- Conditions
- Laparoscopic Surgery
- Keywords
- laparoscopic cholecystectomy BASKA mask Endotracheal tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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 is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as well as reduce perioperative complications.
Detailed description
Patient's satisfaction and smooth process is crucial for perioperative care.Conduct of Anaesthesia including choice of airway devices play an important role. Endotracheal intubation has long been regarded as the technique of choice for airway management in laparoscopic surgery. However, there is currently an emerging interest in laryngeal mask as the substitute for endotracheal tube in laparoscopic surgery.
The increased abdominal pressure secondary to gas insufflation in Laparoscopic surgery demands a good supraglottic airway device with features of good seal, aspiration prevention and effective ventilation.
Few studies have evaluated the performance Baska® Mask for various type of surgery and had obtained high "first-attempt" success rate, easy insertion and a good oropharyngeal leak pressure above 30cmH2O with low complications such as sorethroat, dysphonia and dysphagia.
However, study regarding comparison of Baska® mask with endotracheal tube has not been carried out before. Therefore, the investigators would like to evaluate this novel device in comparison with endotracheal tube for laparoscopic surgery in our centre.
This will be a prospective randomized controlled study in University Malaya Medical Centre to compare Baska® mask with the conventional laryngoscope-guided endotracheal intubation for laparoscopic surgeries.
The investigators would like to study the efficacy of this device in term of : time to effective airway insertion, efficacy of airway seal, post-operation device of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASKA mask | Experimental | Device: BASKA maskSelection of size : size 3 (30-50kg), size 4 (50-70kg), size 5 (70-100kg) |
| Endotracheal intubation | Active comparator | Device: Endotracheal intubationSelection of size : ID 7.0-7.5mm (women), ID 7.5-8.0mm (men) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75 years old
- American Society of Anesthesiologists (ASA) physical status I and II BMI ≤ 35
- Laparoscopic cholecystectomy only
Key exclusion criteria (3 listed)
- Known gastroesophageal reflux
- History of difficult intubation or difficult anaesthesia
- Features of facial, laryngeal and pharyngeal anatomy problem
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 maskBaska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth | Device | BASKA mask |
| Endotracheal intubationEndotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth | Device | Endotracheal intubation |
Primary outcome
Time to effective airway insertion
Time frame: 1 hour
defined as time from picking up the airway device (either BASKA mask or Endotracheal tube), insertion and until occurrence of the first square-waveform capnogram
4 secondary outcomes
Numbers of attempt of airway device insertion and Ease of insertion
Time frame: 1 hour
Gastric distension scoring by surgeon
Time frame: during operative duration
Post operation incidence of complications
Time frame: from the induction of anaesthesia, until at the postanaesthetic care unit (PACU), assessed up to 24 hours
Hemodynamic changes
Time frame: after induction of anaesthesia at 1, 2, 3,4,5,10,20,30 minutes; then post extubation at 1 ,2,3,4,5 minutes
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 7 Jul 2020.
- Derived from this study: PubMed 33322949Ng CC, Sybil Shah MHB, Chaw SH, Mansor MB, Tan WK, Koong JK, Wang CY. Baska mask versus endotracheal tube in laparoscopic cholecystectomy surgery: a prospective randomized trial. Expert Rev Med Devices. 2021 Feb;18(2):203-210. doi: 10.1080/17434440.2021.1865796. Epub 2020 Dec 31.
- 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.
CHING CHOE NG, MMED(ANAES) principal investigator
UNIVERSITY OF MALAYA MEDICAL CENTRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BASKA mask and Endotracheal intubation in people with Laparoscopic Surgery, run by University of Malaya at 1 site in Malaysia.
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 3 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 7 Jul 2020. 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 Malaysia. 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?
Time to effective airway insertion (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045835, which also lists 1 linked publication.
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 7 Jul 2020.