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NCT04215692 Clinical Trial

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

Fluid Overload Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04215692
Other study ID # 2019-R-14
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date December 28, 2025

Study information
Verified date March 2024
Source Instituto Mexicano del Seguro Social
Contact Maricela García-Arellano, MD
Phone 449 994 6720
Email marigarcia8@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 68
Est. completion date December 28, 2025
Est. primary completion date December 15, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Week to 14 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Pulmonary ultrasound
Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.

Locations
Country Name City State
Mexico Centenario Hospital Miguel Hidalgo Aguascalientes

Sponsors (2)
Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social Centenario Hospital Miguel Hidalgo

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of stay Number of days that the patient requires care in the ICU through study completion, an average of 14 days
Secondary 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
Secondary PaO2/FIO2 Ratio of arterial oxygen partial pressure to fractional inspired oxygen Daily through study completion, an average of 14 days
Secondary Duration of mechanical ventilation Days that a patient remains under mechanical ventilation through study completion, an average of 14 days
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