NCT05449886

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

July 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

July 4, 2022

Last Update Submit

July 10, 2022

Conditions

Pediatric ALL

Outcome Measures

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

    from induction of anesthesia to end of operation, about 5 hours

Study Arms (1)

Tidal volume challenge

EXPERIMENTAL
Procedure: TVC

Interventions

TVCPROCEDURE

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

Tidal volume challenge

Eligibility Criteria

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

You may qualify if:

  • elective neurosurgery and requiring prone positioning

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 8, 2022

Study Start

July 12, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

KR(1)