Pediatric ALLNCT05449886
Prone Fluid Responsiveness in Children
A study testing TVC in people with Pediatric ALL, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In pediatric patients in the prone position, the reliability of pulse pressure variation and stroke volume variation, and pleth variability index to predict fluid responsiveness have not previously been established. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- TVC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2022to 31 Jul 2023
- 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 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- elective neurosurgery and requiring prone positioning
Who cannot join
- (1) chronic cardiac arrhythmia; (2) depressed left (<30% of ejection fraction) (3) patients with pulmonary disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hee-Soo Kim
Seoul, 03080
Hee-Soo Kim, MD.PhD, 08201052878006, dami0605@snu.ac.kr
Eun-hee Kim, MD. PhD, 82-2-2072-3661, beloveun@snu.ac.kr
About this study
Official title: Study on the Prediction of Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia With Prone Position
In pediatric patients in the prone position, the reliability of pulse pressure variation and stroke volume variation, and pleth variability index to predict fluid responsiveness have not previously been established. Perioperatively, in this setting, optimizing fluid management can be challenging, and fluid overload is associated with both intraoperative and postoperative complications. The investigator designed this study to assess the sensitivity and specificity of baseline PPV, SVV, and PVI the tidal volume (VT) challenge (VTC) and in predicting fluid responsiveness during elective neurosurgery.
- Conditions
- Pediatric ALL
- Being tested
- TVC
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVCProcedure or surgery
Tidal volume challenge from 6ml/kg to 10ml/kg for 1 min.
| Study group | Role | What they receive |
|---|---|---|
| Tidal volume challenge | Experimental | Not described Receives: Procedure: TVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness prediction using AUC of ROC curve analysis
stroke volume index increase more than 10% from baseline after volume administration (10ml/kg) Fluid responsiveness parameters; PPV, SVV, PVI, rPVI before and after tidal volume challenge
Measured: from induction of anesthesia to end of operation, about 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start12 Jul 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449886
- Sponsor's protocol ID
- 2204-171-1321
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prediction of Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia With Prone Position
- ClinicalTrials.gov ID
- NCT05449886
- Acronym / sponsor ID
- 2204-171-1321
- Conditions
- Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jul 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 8 Jul 2022 (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.
In pediatric patients in the prone position, the reliability of pulse pressure variation and stroke volume variation, and pleth variability index to predict fluid responsiveness have not previously been established. Perioperatively, in this setting, optimizing fluid management can be challenging, and fluid overload is associated with both intraoperative and postoperative complications. The investigator designed this study to assess the sensitivity and specificity of baseline PPV, SVV, and PVI the tidal volume (VT) challenge (VTC) and in predicting fluid responsiveness during elective neurosurgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tidal volume challenge | Experimental | Procedure: TVC |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- elective neurosurgery and requiring prone positioning
Key exclusion criteria (1 listed)
- (1) chronic cardiac arrhythmia; (2) depressed left (<30% of ejection fraction) (3) patients with pulmonary disease
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 |
|---|---|---|
| TVCTidal volume challenge from 6ml/kg to 10ml/kg for 1 min. | Procedure or surgery | Tidal volume challenge |
Primary outcome
fluid responsiveness prediction using AUC of ROC curve analysis
Time frame: from induction of anesthesia to end of operation, about 5 hours
stroke volume index increase more than 10% from baseline after volume administration (10ml/kg) Fluid responsiveness parameters; PPV, SVV, PVI, rPVI before and after tidal volume challenge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVC in people with Pediatric ALL, 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 1 inclusion and 1 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 12 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid responsiveness prediction using AUC of ROC curve analysis (time frame: from induction of anesthesia to end of operation, about 5 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 12 Jul 2022.