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NCT03132480 Clinical Trial

Fluid Responsiveness Using Forehead Sensor in Children

Hypovolemia Clinical Trial

— forehead  

Official title:
Study on TFA-1 Adhesive Forehead Sensors to Predict Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03132480
Other study ID # H1703-137-841
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date August 31, 2018

Study information
Verified date May 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children

Description:

The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• fluid resuscitation
when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.

Locations
Country Name City State
Korea, Republic of SNUH Seoul Jongro Gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the Receiver operating characteristic(ROC) curve (AUC) the predictability of fluid responsiveness was calculated using ROC analysis before fluid resuscitation
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