Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

Not Applicable

Suspended

• Conditions: Fluid Overload; Pneumonia, Ventilator-Associated; Fluid Overload Pulmonary Edema; Fluid Overload Without Edema
• Interventions: Diagnostic Test: Pulmonary ultrasound

• Registration Number: NCT04215692
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

Detailed Description

In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables:

Length of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• All pediatric inpatient intensive care unit admissions
• Signed Informed Consent Form

Exclusion Criteria

• Cyanotic congenital heart disease
• Not requiring mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Fluid Therapy	Pulmonary ultrasound	-

Primary Outcome Measures

Name	Time	Method
Length of stay	through study completion, an average of 14 days	Number of days that the patient requires care in the ICU

Secondary Outcome Measures

Name	Time	Method
PaO2/FIO2	Daily through study completion, an average of 14 days	Ratio of arterial oxygen partial pressure to fractional inspired oxygen
Oxygenation Index	Daily through study completion, an average of 14 days	Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.
Duration of mechanical ventilation	through study completion, an average of 14 days	Days that a patient remains under mechanical ventilation

Trial Locations

Locations (1)

Centenario Hospital Miguel Hidalgo; 🇲🇽 Aguascalientes, Mexico