CholecystitisNCT06502028
Video Laryngeal Mask Versus Endotracheal Tube Undergoing Laparoscopic Cholecystectomy Surgery
A study testing Video laryngeal mask airway and Endotracheal tube in people with Cholecystitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Video laryngeal mask airway and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2024to 7 Apr 2026
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 19 years old
- Patients planned for elective laparoscopic cholecystectomy
Who cannot join
- High risk of aspiration (e.g. gastro-esophageal reflux disease, hiatus hernia, pregnancy, history of gastrectomy)
- Difficult airway (e.g. limitation of mouth opening, limitation of neck extension, oropharyngeal pathology)
- Obesity (BMI > 30 kg/m2)
- Tooth mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Laryngeal Mask Versus Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Surgery Under General Anesthesia: a Prospective Randomized Controlled Trial
The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
The investigators will compare the time required to secure the airway when inserting a video laryngeal mask (LMA) versus performing endotracheal intubation.
- Conditions
- Cholecystitis
- Being tested
- Video laryngeal mask airway, Endotracheal tube
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video laryngeal mask airwayDevice
The airway is secured with a video laryngeal mask airway.
Endotracheal tubeDevice
The participant is intubated with an endotracheal tube via direct laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Video LMA | Experimental | The airway is secured with a video laryngeal mask airway (VLMA). Receives: Device: Video laryngeal mask airway |
| Control | Active comparator | The participant is intubated with an endotracheal tube via direct laryngoscopy. Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for VLMA insertion or intubation
Time required for VLMA insertion or intubation
Measured: After induction of anesthesia, before the operation starts.
Secondary outcomes (10)
Number of trials
Video laryngeal mask airway insertion or endotracheal intubation
Measured: After induction of anesthesia, before the operation starts.
Peak airway pressure
Peak airway pressure
Measured: After video laryngeal mask airway insertion or intubation, before extubation
Minute ventilation
Minute ventilation
Measured: After video laryngeal mask airway insertion or intubation, before extubation
End tidal carbon dioxide
End tidal carbon dioxide
Measured: After video laryngeal mask airway insertion or intubation, before extubation
Oropharyngeal leak pressure
Oropharyngeal leak pressure
Measured: After video laryngeal mask airway insertion or intubation, before extubation
Traces of blood on airway device after extubation
Traces of blood on airway device after extubation
Measured: After extubation, before transfer to PACU
Postoperative sore throat
4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain)
Measured: 1 hour after end of operation
Postoperative sore throat
4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain)
Measured: 24 hours after end of operation
Postoperative hoarseness
4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain)
Measured: 1 hour after end of operation
Postoperative hoarseness
4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain)
Measured: 24 hours after end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start31 Jul 2024
- Primary completion6 Apr 2026
- Study completion7 Apr 2026
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.
- More trials run by Seoul National University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hansol KIM, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502028
- Sponsor's protocol ID
- 2308-160-1461
- Status last verified
- May 2026
- First submitted
- 27 Jun 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Laryngeal Mask Versus Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Surgery Under General Anesthesia: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06502028
- Acronym / sponsor ID
- 2308-160-1461
- Conditions
- Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 15 Jul 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.
The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.
Detailed description
The investigators will compare the time required to secure the airway when inserting a video laryngeal mask (LMA) versus performing endotracheal intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video LMA | Experimental | Device: Video laryngeal mask airwayThe airway is secured with a video laryngeal mask airway (VLMA). |
| Control | Active comparator | Device: Endotracheal tubeThe participant is intubated with an endotracheal tube via direct laryngoscopy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 19 years old
- Patients planned for elective laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- High risk of aspiration (e.g. gastro-esophageal reflux disease, hiatus hernia, pregnancy, history of gastrectomy)
- Difficult airway (e.g. limitation of mouth opening, limitation of neck extension, oropharyngeal pathology)
- Obesity (BMI > 30 kg/m2)
- Tooth mobility
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 |
|---|---|---|
| Video laryngeal mask airwayThe airway is secured with a video laryngeal mask airway. | Device | Video LMA |
| Endotracheal tubeThe participant is intubated with an endotracheal tube via direct laryngoscopy. | Device | Control |
Primary outcome
Time required for VLMA insertion or intubation
Time frame: After induction of anesthesia, before the operation starts.
Time required for VLMA insertion or intubation
10 secondary outcomes
Number of trials
Time frame: After induction of anesthesia, before the operation starts.
Peak airway pressure
Time frame: After video laryngeal mask airway insertion or intubation, before extubation
Minute ventilation
Time frame: After video laryngeal mask airway insertion or intubation, before extubation
End tidal carbon dioxide
Time frame: After video laryngeal mask airway insertion or intubation, before extubation
Oropharyngeal leak pressure
Time frame: After video laryngeal mask airway insertion or intubation, before extubation
Traces of blood on airway device after extubation
Time frame: After extubation, before transfer to PACU
Postoperative sore throat
Time frame: 1 hour after end of operation
Postoperative sore throat
Time frame: 24 hours after end of operation
Postoperative hoarseness
Time frame: 1 hour after end of operation
Postoperative hoarseness
Time frame: 24 hours after end of operation
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 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Cholecystitis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
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.
Hansol KIM, MD principal investigator
Seoul National University 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 Video laryngeal mask airway and Endotracheal tube in people with Cholecystitis, run by Seoul National University Hospital at 1 site in South Korea.
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 19 May 2026. 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 South Korea. 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 required for VLMA insertion or intubation (time frame: After induction of anesthesia, before the operation starts.). 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 19 May 2026.