Prone Fluid Responsiveness in Children

NCT ID: NCT05449886

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric ALL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tidal volume challenge

Group Type EXPERIMENTAL

TVC

Intervention Type PROCEDURE

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

Interventions

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TVC

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* elective neurosurgery and requiring prone positioning

Exclusion Criteria

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

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hee-Soo Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Hee-Soo Kim, MD.PhD

Role: primary

08201052878006

Eun-hee Kim, MD. PhD

Role: backup

82-2-2072-3661

Other Identifiers

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2204-171-1321

Identifier Type: -

Identifier Source: org_study_id

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