Value of Continuous Pressure Monitoring in Laryngeal MaskNCT03654924
Continuous Laryngeal Cuff Pressure Monitoring
A study testing Laryngeal Mask in people with Value of Continuous Pressure Monitoring in Laryngeal Mask, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Value of Continuous Pressure Monitoring in Laryngeal Mask
- What is being tested?
- Laryngeal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2016to 25 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- NUH patients who will undergo wisdom teeth extraction.
Who cannot join
- Patients with tooth braces
- Patients who are at risk of aspiration
- Patients with missing any of incisor tooth
- Pregnant woman
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.
Read the detailed description
The laryngeal mask airway (LMA) is widely used in dental surgery as it provides an unobstructed airway and provides a reliable seal from bleeding and surgical debris. However, there have been few studies of the integrity of the LMA seal during intraoperative surgical manipulation with the use of the LMA.
In general anesthesia using LMA, airway and esophagus cannot be separated completely. Insufficient airway seal become the risk of aspiration in airway management. This study will focus on airway seal following LMA use in dental surgery.
- Being tested
- Laryngeal Mask
- Keywords
- LMA, Leak, Sore Throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal MaskDevice
General anaesthesia using LMA will be performed as per standard procedure. A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously.
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Mask | Experimental | A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously. Receives: Device: Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of continuous LMA cuff pressure monitoring in dental surgery
Measure of intra cuff pressure
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Sep 2016
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Value of Continuous Pressure Monitoring in Laryngeal MaskStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational study
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lian Kah Ti, MBBS, MMed, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654924
- Sponsor's protocol ID
- DSRB 2016/00604
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol, results, analysis
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Laryngeal Cuff Pressure Monitoring
- ClinicalTrials.gov ID
- NCT03654924
- Acronym / sponsor ID
- DSRB 2016/00604
- Keywords
- LMA, Leak, Sore Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 31 Aug 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.
The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.
Detailed description
The laryngeal mask airway (LMA) is widely used in dental surgery as it provides an unobstructed airway and provides a reliable seal from bleeding and surgical debris. However, there have been few studies of the integrity of the LMA seal during intraoperative surgical manipulation with the use of the LMA.
In general anesthesia using LMA, airway and esophagus cannot be separated completely. Insufficient airway seal become the risk of aspiration in airway management. This study will focus on airway seal following LMA use in dental surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational study
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Mask | Experimental | Device: Laryngeal MaskA pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NUH patients who will undergo wisdom teeth extraction.
Key exclusion criteria (5 listed)
- Patients with tooth braces
- Patients who are at risk of aspiration
- Patients with missing any of incisor tooth
- Pregnant woman
- Non-English speaking patients
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 MaskGeneral anaesthesia using LMA will be performed as per standard procedure. A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously. | Device | Laryngeal Mask |
Primary outcome
Utility of continuous LMA cuff pressure monitoring in dental surgery
Time frame: Intra-operatively
Measure of intra cuff pressure
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 30 Mar 2020.
- Individual participant dataSharing planned: Undecided. Study protocol, results, analysis
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.
Lian Kah Ti, MBBS, MMed principal investigator
National University Health System
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 in people with Value of Continuous Pressure Monitoring in Laryngeal Mask, run by National University Hospital, Singapore 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 1 inclusion and 5 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 30 Mar 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 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?
Utility of continuous LMA cuff pressure monitoring in dental surgery (time frame: Intra-operatively). 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 30 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.