Plasma VolumeNCT03963089
Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
A study testing Tidal volume_6mL/kg, Tidal volume_10mL/kg and Tidal volume_14mL/kg in people with Plasma Volume and Tidal Volume, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Plasma Volume, Tidal Volume
- What is being tested?
- Tidal volume_6mL/kg, Tidal volume_10mL/kg and Tidal volume_14mL/kg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2019to 6 Oct 2020
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children younger than 6 years old planned to undergo ventricular septal defect closure or atrial septal defect closure under general anesthesia
Who cannot join
- Children with other complex cardiac defects
- Children with arrhythmia
- Children with preoperatively measured ejection fraction of less than 30%
- Children with underlying pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.
Read the detailed description
Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.
The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.
In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.
Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.
With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.
- Conditions
- Plasma Volume, Tidal Volume
- Being tested
- Tidal volume_6mL/kg, Tidal volume_10mL/kg, Tidal volume_14mL/kg, Fluid loading
- Keywords
- Fluid Therapy, Hemodynamic Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume_6mL/kgProcedure or surgery
Set tidal volume to 6mL/kg for 1 minute
Tidal volume_10mL/kgProcedure or surgery
Set tidal volume to 10mL/kg for 1 minute
Tidal volume_14mL/kgProcedure or surgery
Set tidal volume to 10mL/kg for 1 minute
Fluid loadingProcedure or surgery
Administer 10mL/kg of crystalloid for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Measure pulse pressure variation and systolic pressure variation after each set of tidal volume to 6mL/kg, 10mL/kg and 14mL/kg. Measure respiratory variation of aortic blood flow peak velocity via transesophageal echocardiography at tidal volume of 10mL/kg.
Measure stroke volume index via transesophageal echocardiography before and 5 min after fluid loading with 10mL/kg of crystalloid. Receives: Procedure: Tidal volume_6mL/kg; Procedure: Tidal volume_10mL/kg; Procedure: Tidal volume_14mL/kg; Procedure: Fluid loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume index
Define subject that shows increase of stroke volume index more than 15% after 10mL/kg of fluid loading as fluid responder, otherwise as non-responder
Measured: From sternal closure to 5 minutes after fluid loading
Predictability_PPV and SPV
Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of pulse pressure variation and systolic pressure variation after each change of set tidal volume
Measured: From sternal closure to 5 minutes after fluid loading
Secondary outcomes (2)
Predictability_△Vpeak
Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of respiratory variation of aortic blood flow peak velocity measured via transesophageal echocardiography at tidal volume of 10mL/kg
Measured: From sternal closure to 5 minutes after fluid loading
Grey zone
Compare the range that the prediction of fluid responsiveness is unreliable (grey zone) for each variable in each set tidal volume
Measured: From sternal closure to 5 minutes after fluid loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start30 May 2019
- Primary completion23 Jun 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Plasma VolumeStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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, M.D, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963089
- Sponsor's protocol ID
- 1902-119-1013
- Status last verified
- May 2022
- First submitted
- 19 May 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 24257389Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.
PubMed 18259726Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.
PubMed 23250892Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
PubMed 21705869Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.
PubMed 28974059
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
- ClinicalTrials.gov ID
- NCT03963089
- Acronym / sponsor ID
- 1902-119-1013
- Conditions
- Plasma Volume, Tidal Volume
- Keywords
- Fluid Therapy, Hemodynamic Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 24 May 2019 (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.
This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.
Detailed description
Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.
The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.
In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.
Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.
With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Tidal volume_6mL/kg, Procedure: Tidal volume_10mL/kg, Procedure: Tidal volume_14mL/kg, Procedure: Fluid loadingMeasure pulse pressure variation and systolic pressure variation after each set of tidal volume to 6mL/kg, 10mL/kg and 14mL/kg. Measure respiratory variation of aortic blood flow peak velocity via transesophageal echocardiography at tidal volume of 10mL/kg. Measure stroke volume index via transesophageal echocardiography before and 5 min after fluid loading with 10mL/kg of crystalloid. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children younger than 6 years old planned to undergo ventricular septal defect closure or atrial septal defect closure under general anesthesia
Key exclusion criteria (4 listed)
- Children with other complex cardiac defects
- Children with arrhythmia
- Children with preoperatively measured ejection fraction of less than 30%
- Children with underlying 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 |
|---|---|---|
| Tidal volume_6mL/kgSet tidal volume to 6mL/kg for 1 minute | Procedure or surgery | Study group |
| Tidal volume_10mL/kgSet tidal volume to 10mL/kg for 1 minute | Procedure or surgery | Study group |
| Tidal volume_14mL/kgSet tidal volume to 10mL/kg for 1 minute | Procedure or surgery | Study group |
| Fluid loadingAdminister 10mL/kg of crystalloid for 5 minutes | Procedure or surgery | Study group |
Primary outcome
Stroke volume index
Time frame: From sternal closure to 5 minutes after fluid loading
Define subject that shows increase of stroke volume index more than 15% after 10mL/kg of fluid loading as fluid responder, otherwise as non-responder
Predictability_PPV and SPV
Time frame: From sternal closure to 5 minutes after fluid loading
Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of pulse pressure variation and systolic pressure variation after each change of set tidal volume
2 secondary outcomes
Predictability_△Vpeak
Time frame: From sternal closure to 5 minutes after fluid loading
Grey zone
Time frame: From sternal closure to 5 minutes after fluid loading
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 5 May 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 18259726Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.
- Background: PubMed 23250892Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.
- Background: PubMed 21705869Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
- Background: PubMed 28974059Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.
- 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.
Jin-Tae Kim, M.D, Ph.D. 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 Tidal volume_6mL/kg, Tidal volume_10mL/kg and Tidal volume_14mL/kg in people with Plasma Volume and Tidal Volume, 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 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 5 May 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?
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?
Stroke volume index (time frame: From sternal closure to 5 minutes after fluid loading). The study lists 2 primary outcomes in all. 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 NCT03963089, which also lists 5 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 5 May 2022.