Prone Fluid Responsiveness in Children

Pediatric ALL Clinical Trial

Official title:

Study on the Prediction of Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia With Prone Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449886
• Other study ID #: 2204-171-1321
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric ALL

Intervention

Procedure:
• TVC
Tidal volume challenge from 6ml/kg to 10ml/kg for 1 min.

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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