Back to resultsFluid Responsiveness Using Forehead Sensor in Children (forehead)
Primary Purpose
Hypovolemia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fluid resuscitation
Sponsored by
About this trial
This is an interventional device feasibility trial for Hypovolemia
Eligibility Criteria
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
Sites / Locations
- SNUH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hypovolemia
Arm Description
Outcomes
Primary Outcome Measures
Area under the Receiver operating characteristic(ROC) curve (AUC)
the predictability of fluid responsiveness was calculated using ROC analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT03132480
First Posted
April 24, 2017
Last Updated
May 7, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03132480
Brief Title
Fluid Responsiveness Using Forehead Sensor in Children
Acronym
forehead
Official Title
Study on TFA-1 Adhesive Forehead Sensors to Predict Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypovolemia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
fluid resuscitation
Intervention Description
when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.
Primary Outcome Measure Information:
Title
Area under the Receiver operating characteristic(ROC) curve (AUC)
Description
the predictability of fluid responsiveness was calculated using ROC analysis
Time Frame
before fluid resuscitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
SNUH
City
Seoul
State/Province
Jongro Gu
ZIP/Postal Code
15710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32412989
Citation
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.
Results Reference
derived
Learn more about this trial
Fluid Responsiveness Using Forehead Sensor in Children
We'll reach out to this number within 24 hrs