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

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

Study Overview

• Status: Suspended
• Conditions: Fluid Overload; Pneumonia, Ventilator-Associated; Fluid Overload Pulmonary Edema; Fluid Overload Without Edema
• Intervention / Treatment: Diagnostic test: Pulmonary ultrasound

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Aguascalientes, Mexico, 20259
    • Centenario Hospital Miguel Hidalgo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Cyanotic congenital heart disease
• Not requiring mechanical ventilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound Guided Fluid Therapy	Diagnostic test: Pulmonary ultrasound; Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.
No Intervention: Conventional Fluid Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Number of days that the patient requires care in the ICU	through study completion, an average of 14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Collaborators: Centenario Hospital Miguel Hidalgo

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 28, 2025

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pediatric intensive care; lenght of stay
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pulmonary Edema; Pneumonia, Ventilator-Associated; Edema
• Other Study ID Numbers: 2019-R-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to share the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No