- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132480
Fluid Responsiveness Using Forehead Sensor in Children (forehead)
May 7, 2019 updated by: Hee-Soo Kim, Seoul National University Hospital
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
Study Overview
Detailed Description
The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jongro Gu
-
Seoul, Jongro Gu, Korea, Republic of, 15710
- SNUH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pediatric patients undergoing general anesthesia for neurosurgery, major abdominal surgery, and cardiac surgical procedures.
Exclusion Criteria:
- preoperative Ejection fraction <30%
- underlying lung disease
- cardiac arrhythmia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hypovolemia
|
when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the Receiver operating characteristic(ROC) curve (AUC)
Time Frame: before fluid resuscitation
|
the predictability of fluid responsiveness was calculated using ROC analysis
|
before fluid resuscitation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
April 24, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (Actual)
April 27, 2017
Study Record Updates
Last Update Posted (Actual)
May 9, 2019
Last Update Submitted That Met QC Criteria
May 7, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1703-137-841
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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