CClinicalTrials.gg
Status unknownNCT05449886Updated Jul 12, 2022

Prone Fluid Responsiveness in Children

An interventional study of TVC in Pediatric ALL, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
1 Month to 6 Years
Sex
All
01

Study summary

In pediatric patients in the prone position, the reliability of pulse pressure variation and stroke volume variation, and pleth variability index to predict fluid responsiveness have not previously been established. Perioperatively, in this setting, optimizing fluid management can be challenging, and fluid overload is associated with both intraoperative and postoperative complications. The investigator designed this study to assess the sensitivity and specificity of baseline PPV, SVV, and PVI the tidal volume (VT) challenge (VTC) and in predicting fluid responsiveness during elective neurosurgery.

02

Conditions studied

  • Pediatric ALL
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • elective neurosurgery and requiring prone positioning

Exclusion criteria

Exclusion Criteria:

  • (1) chronic cardiac arrhythmia; (2) depressed left (\<30% of ejection fraction) (3) patients with pulmonary disease
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Tidal volume challenge

    Procedure: TVC

Interventions

  • ProcedureTVC

    Tidal volume challenge from 6ml/kg to 10ml/kg for 1 min.

06

What researchers measure

Primary outcomes

  1. fluid responsiveness prediction using AUC of ROC curve analysis

    stroke volume index increase more than 10% from baseline after volume administration (10ml/kg) Fluid responsiveness parameters; PPV, SVV, PVI, rPVI before and after tidal volume challenge

    Time frame: from induction of anesthesia to end of operation, about 5 hours

07

Study locations

1 of 1 sites recruiting
  • Hee-Soo Kim
    Seoul, 03080, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05449886
Lead sponsor
Seoul National University Hospital
Responsible party
Hee-Soo Kim (professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 8, 2022
Start date
Jul 12, 2022 (estimated)
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Jul 12, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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