CholecystitisNCT02037958
Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
A study testing Laryngeal Mask Airway-Supreme and Endotracheal Tube in people with Cholecystitis and Choledocholithiasis, run by Changi General Hospital at 1 site in Singapore.
Trial summary
We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cholecystitis, Choledocholithiasis
- What is being tested?
- Laryngeal Mask Airway-Supreme and Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2011to Jan 2012
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status 1 and 2
- Undergoing elective laparoscopic cholecystectomy
Who cannot join
- BMI > 30
- Known gastro-oesophageal reflux disease
- predicted or documented difficult airway
- contraindications to drugs in the standardized anaesthesia protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial
We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.
Read the detailed description
The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.
- Conditions
- Cholecystitis, Choledocholithiasis
- Being tested
- Laryngeal Mask Airway-Supreme, Endotracheal Tube
- Medical subject headings
- Cholecystitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask Airway-SupremeDevice
Also called LMA-S, LMA-Supreme, LMA Supreme
Patients who receive the LMA-S
Endotracheal TubeDevice
Also called ETT, Tracheal Tube
Patients who receive endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Mask Airway-Supreme | Experimental | Patients who are randomly assigned to receive the LMA-Supreme Receives: Device: Laryngeal Mask Airway-Supreme |
| Endotracheal Tube | Active comparator | Patients who are randomly assigned to receive endotracheal intubation Receives: Device: Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Effective Airway
Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation
Measured: Baseline
Secondary outcomes (5)
Number of attempts taken for successful placement of airway device
Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned
Measured: Baseline
Number of attempts taken for successful placement of gastric tube
Number of attempts needed for successful placement of gastric tube. Correct gastric tube placement was determined by positive suctioning of gastric contents or detection of injected air with epigastric auscultation.
Measured: Baseline
Haemodynamic response to insertion of airway device
Systolic blood pressure and heart rate at 0 min, 1 min, 5 min, starting from the time the face mask was removed from the patient's face.
Measured: Baseline, 1 min, 5 min
Peak airway pressure during pneumoperitoneum
Peak airway pressure recorded during pneumoperitoneum, measured during the surgery
Measured: Assessed intra-operatively, during the period of pneumoperitoneum
Incidence of post-operative sore throat
Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr after the end of surgery. No further follow-up.
Measured: Assessed 1 hr after the surgery, at the Recovery Area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin Quek How Yow, Changi General Hospital
- Investigators
- Kelvin Quek, MMED (Anaes), Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037958
- Sponsor's protocol ID
- CGHLMAS2010
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02037958
- Acronym / sponsor ID
- CGHLMAS2010
- Conditions
- Cholecystitis, Choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Jan 2014 (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.
We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.
Detailed description
The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Mask Airway-Supreme | Experimental | Device: Laryngeal Mask Airway-SupremePatients who are randomly assigned to receive the LMA-Supreme |
| Endotracheal Tube | Active comparator | Device: Endotracheal TubePatients who are randomly assigned to receive endotracheal intubation |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) Physical Status 1 and 2
- Undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- BMI > 30
- Known gastro-oesophageal reflux disease
- predicted or documented difficult airway
- contraindications to drugs in the standardized anaesthesia protocol
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 |
|---|---|---|
| Laryngeal Mask Airway-SupremeAlso: LMA-S, LMA-Supreme, LMA SupremePatients who receive the LMA-S | Device | Laryngeal Mask Airway-Supreme |
| Endotracheal TubeAlso: ETT, Tracheal TubePatients who receive endotracheal intubation | Device | Endotracheal Tube |
Primary outcome
Time to Effective Airway
Time frame: Baseline
Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation
5 secondary outcomes
Number of attempts taken for successful placement of airway device
Time frame: Baseline
Number of attempts taken for successful placement of gastric tube
Time frame: Baseline
Haemodynamic response to insertion of airway device
Time frame: Baseline, 1 min, 5 min
Peak airway pressure during pneumoperitoneum
Time frame: Assessed intra-operatively, during the period of pneumoperitoneum
Incidence of post-operative sore throat
Time frame: Assessed 1 hr after the surgery, at the Recovery Area
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 16 Jan 2014.
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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.
Kelvin Quek, MMED (Anaes) principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway-Supreme and Endotracheal Tube in people with Cholecystitis and Choledocholithiasis, run by Changi General Hospital at 1 site in Singapore.
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 2 inclusion and 4 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 16 Jan 2014. 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 Singapore. 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 (time frame: Baseline). 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 16 Jan 2014.