HypovolemiaforeheadNCT03132480
Fluid Responsiveness Using Forehead Sensor in Children
A study testing fluid resuscitation in people with Hypovolemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Hypovolemia
- What is being tested?
- fluid resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 31 Aug 2018
- 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 for neurosurgery, major abdominal surgery, and cardiac surgical procedures.
Who cannot join
- preoperative Ejection fraction <30%
- underlying lung disease
- cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on TFA-1 Adhesive Forehead Sensors to Predict Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia
Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children
Read the detailed description
The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.
- Conditions
- Hypovolemia
- Being tested
- fluid resuscitation
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid resuscitationOther
when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.
| Study group | Role | What they receive |
|---|---|---|
| hypovolemia | Experimental | Not described Receives: Other: fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver operating characteristic(ROC) curve (AUC)
the predictability of fluid responsiveness was calculated using ROC analysis
Measured: before fluid resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Jun 2018
- Study completion31 Aug 2018
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
- Device feasibility
- 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, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132480
- Sponsor's protocol ID
- H1703-137-841
- Acronym
- forehead
- Status last verified
- May 2019
- First submitted
- 24 Apr 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim EH, Kim H, Lee JH, Kim JT, Jang YE, Ji SH, Kim HS. Role of TFA-1 adhesive forehead sensors in predicting fluid responsiveness in anaesthetised children: A prospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):713-718. doi: 10.1097/EJA.0000000000001235.
PubMed 32412989
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on TFA-1 Adhesive Forehead Sensors to Predict Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03132480
- Acronym / sponsor ID
- forehead / H1703-137-841
- Conditions
- Hypovolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 27 Apr 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.
Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children
Detailed description
The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypovolemia | Experimental | Other: fluid resuscitation |
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 for neurosurgery, major abdominal surgery, and cardiac surgical procedures.
Key exclusion criteria (3 listed)
- preoperative Ejection fraction <30%
- underlying lung disease
- cardiac arrhythmia
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 resuscitationwhen the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed. | Other | hypovolemia |
Primary outcome
Area under the Receiver operating characteristic(ROC) curve (AUC)
Time frame: before fluid resuscitation
the predictability of fluid responsiveness was calculated using ROC analysis
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 9 May 2019.
- Derived from this study: PubMed 32412989Kim EH, Kim H, Lee JH, Kim JT, Jang YE, Ji SH, Kim HS. Role of TFA-1 adhesive forehead sensors in predicting fluid responsiveness in anaesthetised children: A prospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):713-718. doi: 10.1097/EJA.0000000000001235.
- 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.
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 fluid resuscitation 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 9 May 2019. 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?
Area under the Receiver operating characteristic(ROC) curve (AUC) (time frame: before fluid resuscitation). 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 NCT03132480, 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 9 May 2019.