AnesthesiaNCT05601622
RPVI for Fluid Responsiveness in Children
A study testing Fluid loading, Transthoracic echocardiography and PVI, RPVI in people with Anesthesia and Fluid Responsiveness, run by Seoul National University Hospital.
Trial summary
The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Anesthesia, Fluid Responsiveness
- What is being tested?
- Fluid loading, Transthoracic echocardiography and PVI, RPVI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2022to 20 Oct 2024
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing neurosurgery under general anesthesia
Who cannot join
- Presence of any cardiovascular disease
- Presence of any pulmonary disease
- Decline of enrollment from any of the patient's parents
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children
The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.
Read the detailed description
Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg.
To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI.
According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.
- Conditions
- Anesthesia, Fluid Responsiveness
- Being tested
- Fluid loading, Transthoracic echocardiography, PVI, RPVI, Tidal volume change
- Keywords
- Fluid responsiveness, pleth variability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loadingProcedure or surgery
Intravenous administration of 10ml/kg of crystalloids over 10 minutes
Transthoracic echocardiographyDiagnostic test
Transthoracic echocardiographic measurement of stroke volume index
PVI, RPVIDiagnostic test
Continuous measurement of pleth variability index and Rainbow pleth variability index
Tidal volume changeProcedure or surgery
Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Fluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation Receives: Procedure: Fluid loading; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: PVI, RPVI; Procedure: Tidal volume change |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ROC curve
Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness
Measured: From start of anesthesia to end of anesthesia, Less than 24 hours
Secondary outcomes (3)
Appearance of abnormal heart rhythm
Electrocardiogram during the study for monitoring whether tachycardia, bradycardia, or arrhythmia appears. Heart rate will be compared between patients who were fluid responsive and who were not responsive.
Measured: From start of anesthesia to end of study, Less than 24 hours
IBP
Invasive blood pressure during the study, including systolic, diastolic, mean blood pressure for monitoring whether hypertension or hypotension appears. Mean blood pressure will be compared between patients who were fluid responsive and who were not responsive.
Measured: From start of anesthesia to end of study, Less than 24 hours
SpO2
Pulse oximetry during the study for monitoring whether hypoxia appears.
Measured: From start of anesthesia to end of study, Less than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- 45 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
- Investigators
- Hee-Soo Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601622
- Sponsor's protocol ID
- 2209-123-1363
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e.
PubMed 24257389Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. doi: 10.1542/peds.112.4.793.
PubMed 14523168Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children
- ClinicalTrials.gov ID
- NCT05601622
- Acronym / sponsor ID
- 2209-123-1363
- Conditions
- Anesthesia, Fluid Responsiveness
- Keywords
- Fluid responsiveness, pleth variability index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 1 Nov 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.
The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.
Detailed description
Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg.
To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI.
According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Fluid loading, Diagnostic Test: Transthoracic echocardiography, Diagnostic Test: PVI, RPVI, Procedure: Tidal volume changeFluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children undergoing neurosurgery under general anesthesia
Key exclusion criteria (3 listed)
- Presence of any cardiovascular disease
- Presence of any pulmonary disease
- Decline of enrollment from any of the patient's parents
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 |
|---|---|---|
| Fluid loadingIntravenous administration of 10ml/kg of crystalloids over 10 minutes | Procedure or surgery | Study group |
| Transthoracic echocardiographyTransthoracic echocardiographic measurement of stroke volume index | Diagnostic test | Study group |
| PVI, RPVIContinuous measurement of pleth variability index and Rainbow pleth variability index | Diagnostic test | Study group |
| Tidal volume changeChanging tidal volume for mechanical ventilation as 6, 8, 10 ml/kg | Procedure or surgery | Study group |
Primary outcome
AUC of ROC curve
Time frame: From start of anesthesia to end of anesthesia, Less than 24 hours
Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness
3 secondary outcomes
Appearance of abnormal heart rhythm
Time frame: From start of anesthesia to end of study, Less than 24 hours
IBP
Time frame: From start of anesthesia to end of study, Less than 24 hours
SpO2
Time frame: From start of anesthesia to end of study, Less than 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 24257389Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e.
- Background: PubMed 14523168Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. doi: 10.1542/peds.112.4.793.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Individual participant dataSharing planned: No
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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.
Hee-Soo Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fluid loading, Transthoracic echocardiography and PVI, RPVI in people with Anesthesia and Fluid Responsiveness, 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 3 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 16 Nov 2022. 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. 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 Sang-Hwan Ji, M.D., Ph.D. (+82220723661, taepoongshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of ROC curve (time frame: From start of anesthesia to end of anesthesia, Less than 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601622, which also lists 3 linked publications.
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 Nov 2022.