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

NCT ID: NCT04215692

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2025-12-28

Brief Summary

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

Detailed Description

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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

Conditions

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Fluid Overload Pulmonary Edema Fluid Overload Pneumonia, Ventilator-Associated Fluid Overload Without Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ultrasound Guided Fluid Therapy

Group Type EXPERIMENTAL

Pulmonary ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Conventional Fluid Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulmonary ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cyanotic congenital heart disease
* Not requiring mechanical ventilation
Minimum Eligible Age

1 Week

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centenario Hospital Miguel Hidalgo

OTHER

Sponsor Role collaborator

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Juan Manuel Marquez Romero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centenario Hospital Miguel Hidalgo

Aguascalientes, Aguascalientes, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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2019-R-14

Identifier Type: -

Identifier Source: org_study_id

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