AspirationNCT04494802
The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient
A study testing lower pressure and higher pressure in people with Aspiration, run by Seoul National University Hospital.
Trial summary
Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Aspiration
- What is being tested?
- lower pressure and higher pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2020to 10 Aug 2021
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients undergoing general anesthesia with LMA flexible
Who cannot join
- Unstable vital sign, significant arrhythmia or hypotension, Shock
- anticipated difficult intubation or the patient who have facial deformity
- high risk of aspiration
- recent upper respiratory tract infection history
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients
Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.
- Conditions
- Aspiration
- Being tested
- lower pressure, higher pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower pressureBehavioural
During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
higher pressureBehavioural
During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
| Study group | Role | What they receive |
|---|---|---|
| higher pressure | Placebo comparator | During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O Receives: Behavioral: higher pressure |
| lower pressure | Experimental | During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O Receives: Behavioral: lower pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric insufflation(antrum)
Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound
Measured: During the surgery(up to 3 hours)
Secondary outcomes (11)
The size of gastric antrum and body
The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery
Measured: During the surgery(up to 3 hours)
Time for insertion of LMA flexible
Time for insertion of LMA flexible
Measured: During the anesthesia induction(up to 1 hour)
Success rate of insertion of LMA flexible
Success rate of insertion of LMA flexible
Measured: During the anesthesia induction(up to 1 hour)
The number of insertion attempt
The number of insertion attempt
Measured: During the anesthesia induction(up to 1 hour)
The number and the type of additional manipulation for successful ventilation
The number and the type of additional manipulation for successful ventilation
Measured: During the surgery(up to 3 hours)
Ease of insertion of LMA flexible
Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult)
Measured: During the anesthesia induction(up to 1 hour)
Incidence of gastric insufflation(body)
Incidence of gastric insufflation which was recognized in gastric body with ultrasound
Measured: During the surgery(up to 3 hours)
Incidence of gastric insufflation recognized with the ausculation
Incidence of gastric insufflation recognized with the ausculation after finishing surgery
Measured: During the surgery(up to 3 hours)
peak pressure observed before, during, after surgery
peak pressure observed before, during, after surgery
Measured: During the surgery(up to 3 hours)
oropharyngeal leak pressure
oropharyngeal leak pressure will be assessed by setting the APL valve of the circle system at 30 cmH2O with fresh gas flow of 3 L/min after the surgery
Measured: During the surgery(up to 3 hours)
the complication rate
the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration
Measured: During the surgery and after surgery (up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start10 Aug 2020 (estimated)
- Primary completion10 Aug 2021 (estimated)
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspirationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494802
- Sponsor's protocol ID
- Gastric insufflation
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04494802
- Acronym / sponsor ID
- Gastric insufflation
- Conditions
- Aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2020 (estimated)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 31 Jul 2020 (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.
Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| higher pressure | Placebo comparator | Behavioral: higher pressureDuring the operation, cuff pressure of LMA flexible is maintained to 50cmH2O |
| lower pressure | Experimental | Behavioral: lower pressureDuring the operation, cuff pressure of LMA flexible is maintained to 30cmH2O |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients undergoing general anesthesia with LMA flexible
Key exclusion criteria (4 listed)
- Unstable vital sign, significant arrhythmia or hypotension, Shock
- anticipated difficult intubation or the patient who have facial deformity
- high risk of aspiration
- recent upper respiratory tract infection history
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 |
|---|---|---|
| lower pressureDuring the operation, cuff pressure of LMA flexible is maintained to 30cmH2O | Behavioural | lower pressure |
| higher pressureDuring the operation, cuff pressure of LMA flexible is maintained to 50cmH2O | Behavioural | higher pressure |
Primary outcome
Incidence of gastric insufflation(antrum)
Time frame: During the surgery(up to 3 hours)
Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound
11 secondary outcomes
The size of gastric antrum and body
Time frame: During the surgery(up to 3 hours)
Time for insertion of LMA flexible
Time frame: During the anesthesia induction(up to 1 hour)
Success rate of insertion of LMA flexible
Time frame: During the anesthesia induction(up to 1 hour)
The number of insertion attempt
Time frame: During the anesthesia induction(up to 1 hour)
The number and the type of additional manipulation for successful ventilation
Time frame: During the surgery(up to 3 hours)
Ease of insertion of LMA flexible
Time frame: During the anesthesia induction(up to 1 hour)
Incidence of gastric insufflation(body)
Time frame: During the surgery(up to 3 hours)
Incidence of gastric insufflation recognized with the ausculation
Time frame: During the surgery(up to 3 hours)
peak pressure observed before, during, after surgery
Time frame: During the surgery(up to 3 hours)
oropharyngeal leak pressure
Time frame: During the surgery(up to 3 hours)
the complication rate
Time frame: During the surgery and after surgery (up to 6 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing lower pressure and higher pressure in people with Aspiration, run by Seoul National University Hospital.
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 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: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jin-Tae Kim, PhD (82-2-2072-3664, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gastric insufflation(antrum) (time frame: During the surgery(up to 3 hours)). 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 4 Aug 2020.