HypovolemiaNCT03184961
Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children
A study testing lung recruitment maneuver in people with Hypovolemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Hypovolemia
- What is being tested?
- lung recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2017to 31 May 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients undergoing general anesthesia under 6 years old
Who cannot join
- arrhythmia
- <30%, ejection fraction
- lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Variables Able to Predict Fluid Responsiveness Using Lung Recruitment Maneuver in Pediatric Patients Undergoing General Anesthesia
Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation
- Conditions
- Hypovolemia
- Being tested
- lung recruitment maneuver
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment maneuverDiagnostic test
Lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s)
| Study group | Role | What they receive |
|---|---|---|
| lung recruitment maneuver | Experimental | Heart rate, mean arterial pressure, stroke volume, pulse pressure variations, pleth variability index, and photoplethysmographic waveform were recorded before lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s), during lung recruitment maneuver when stroke volume reached its minimal value.
Cardiac index measured before and after volume expansion (10ml/kg saline, 0.9%, infused during 10 min). Patients were considered as responders to fluid administration if cardiac index increased greater than or equal to 15%. Receives: Diagnostic Test: lung recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
photoplethysmographic waveform
Measured: change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies 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
- Other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184961
- Sponsor's protocol ID
- H1704-042-836
- Status last verified
- May 2020
- First submitted
- 8 Jun 2017
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim EH, Lee JH, Jang YE, Ji SH, Kim HS, Cho SA, Kim JT. Prediction of fluid responsiveness using lung recruitment manoeuvre in paediatric patients receiving lung-protective ventilation: A prospective observational study. Eur J Anaesthesiol. 2021 May 1;38(5):452-458. doi: 10.1097/EJA.0000000000001387.
PubMed 33186310
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Variables Able to Predict Fluid Responsiveness Using Lung Recruitment Maneuver in Pediatric Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03184961
- Acronym / sponsor ID
- H1704-042-836
- Conditions
- Hypovolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 14 Jun 2017 (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.
Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung recruitment maneuver | Experimental | Diagnostic Test: lung recruitment maneuverHeart rate, mean arterial pressure, stroke volume, pulse pressure variations, pleth variability index, and photoplethysmographic waveform were recorded before lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s), during lung recruitment maneuver when stroke volume reached its minimal value. Cardiac index measured before and after volume expansion (10ml/kg saline, 0.9%, infused during 10 min). Patients were considered as responders to fluid administration if cardiac index increased greater than or equal to 15%. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients undergoing general anesthesia under 6 years old
Key exclusion criteria (3 listed)
- arrhythmia
- <30%, ejection fraction
- lung 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 |
|---|---|---|
| lung recruitment maneuverLung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s) | Diagnostic test | lung recruitment maneuver |
Primary outcome
photoplethysmographic waveform
Time frame: change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds
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 29 May 2020.
- Derived from this study: PubMed 33186310Kim EH, Lee JH, Jang YE, Ji SH, Kim HS, Cho SA, Kim JT. Prediction of fluid responsiveness using lung recruitment manoeuvre in paediatric patients receiving lung-protective ventilation: A prospective observational study. Eur J Anaesthesiol. 2021 May 1;38(5):452-458. doi: 10.1097/EJA.0000000000001387.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung recruitment maneuver in people with Hypovolemia, 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 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: finished, as of the sponsor's last update on 29 May 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 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?
photoplethysmographic waveform (time frame: change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds). 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 NCT03184961, which also lists 1 linked publication.
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 29 May 2020.