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

March 4, 2024 updated by: Juan Manuel Marquez Romero, Instituto Mexicano del Seguro Social
A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Aguascalientes, Mexico, 20259
        • Recruiting
        • Centenario Hospital Miguel Hidalgo
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: through study completion, an average of 14 days
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
Time Frame: Daily through study completion, an average of 14 days
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
Time Frame: Daily through study completion, an average of 14 days
Ratio of arterial oxygen partial pressure to fractional inspired oxygen
Daily through study completion, an average of 14 days
Duration of mechanical ventilation
Time Frame: through study completion, an average of 14 days
Days that a patient remains under mechanical ventilation
through study completion, an average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Collaborators

Centenario Hospital Miguel Hidalgo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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