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Fluid Responsiveness Using Forehead Sensor in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03132480
Acronym
forehead
Enrollment
30
Registered
2017-04-27
Start date
2017-06-01
Completion date
2018-08-31
Last updated
2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia

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.

Interventions

OTHERfluid resuscitation

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Area under the Receiver operating characteristic(ROC) curve (AUC)before fluid resuscitationthe predictability of fluid responsiveness was calculated using ROC analysis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026