NCT03132480

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

April 24, 2017

Last Update Submit

May 7, 2019

Conditions

Hypovolemia

Outcome Measures

Primary Outcomes (1)

  • Area under the Receiver operating characteristic(ROC) curve (AUC)

    the predictability of fluid responsiveness was calculated using ROC analysis

    before fluid resuscitation

Study Arms (1)

hypovolemia

EXPERIMENTAL
Other: fluid resuscitation

Interventions

fluid resuscitationOTHER

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

hypovolemia

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients undergoing general anesthesia for neurosurgery, major abdominal surgery, and cardiac surgical procedures.

You may not qualify if:

  • preoperative Ejection fraction \<30%
  • underlying lung disease
  • cardiac arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32412989DERIVED

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 27, 2017

Study Start

June 1, 2017

Primary Completion

June 30, 2018

Study Completion

August 31, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)