Assess the Potential of the IVC Distensibility Index as a Predictor of Postoperative Fluid Status in Children.

NCT06957171 | Completed DMC

• 1 other identifier: FMASU MS 728/2024
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will assess the relationship between the amount of fluid administered during pediatric surgery and the subsequent IVC distensibility index postoperatively.

Conditions

Intraoperative Fluid Volume; Inferior Vena Cava Diameter

Outcome Measures

Primary Outcomes (1)

• Inferior Vena Cava distensibility index

  All ultrasonographic measurments of IVC will be performed at the end of surgery, before extubation (patient is anaesthetized and completely relaxed, in the supine position, PEEP less than 7 cmH2O and tidal volume 6-8 ml/kg The probe will be placed at the sub xiphoid area and measurements will be obtained in M-mode imaging performed 2 to 3 cm distal to the right atrium in the long-axis subcostal view..IVC diameter during inspiration (IVCi) and expiration (IVCe) will be measured, Collapsibility index (CI) measured as difference between IVCe, IVCi divided on IVCe (CI = IVCe - IVCi /IVCe x100).

  At the end of surgery, before extubation

Study Arms (6)

Group 1: Age 1-4 years, Conservative Fluid

Patients aged 1 to 4 years receiving intraoperative fluid \<10 ml/kg/h.

Group 2: Age 1-4 years, Liberal Fluid

Patients aged 1 to 4 years receiving intraoperative fluid ≥10 ml/kg/h.

Group 3: Age 4-8 years, Conservative Fluid

Patients aged 4 to 8 years receiving intraoperative fluid \<10 ml/kg/h.

Group 4: Age 4-8 years, Liberal Fluid

Patients aged 4 to 8 years receiving intraoperative fluid ≥10 ml/kg/h.

Group 5: Age 8-12 years, Conservative Fluid

Patients aged 8 to 12 years receiving intraoperative fluid \<10 ml/kg/h.

Group 6: Age 8-12 years, Liberal Fluid

Patients aged 8 to 12 years receiving intraoperative fluid ≥10 ml/kg/h.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will include pediatric patients aged 1-12 years undergoing elective surgery under general anesthesia.

You may qualify if:

• Pediatric patients aged 1-12 years.
• ASA status I - II
• Patients undergoing elective surgical procedures requiring general anesthesia.

You may not qualify if:

• Patients with known congenital heart disease, valvular heart disease or Pulmonary hypertension
• Renal disorders (Acute or Chronic).
• PEEP more than 7 cmH2O at time of assessment of IVC distensibility index

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

Study Officials

• Rawan Abu Deif, M.B.B.CH

  Anaesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: April 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2026
• Access Criteria: Free

Locations

EG (1)