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Completed

NCT Number: NCT03132480

Fluid Responsiveness Using Forehead Sensor in Children

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

Completed

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Seoul, Jongro Gu, 15710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Resuscitation

Other

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

Primary outcomes

  1. Area under the Receiver operating characteristic(ROC) curve (AUC)

    Time frame: before fluid resuscitation

    the predictability of fluid responsiveness was calculated using ROC analysis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: forehead

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2017
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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