Back to resultsLung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
Primary Purpose
Fluid Overload Pulmonary Edema, Fluid Overload, Pneumonia, Ventilator-Associated
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Pulmonary ultrasound
Sponsored by
About this trial
This is an interventional supportive care trial for Fluid Overload Pulmonary Edema focused on measuring pediatric intensive care, lenght of stay
Eligibility Criteria
Inclusion Criteria:
- All pediatric inpatient intensive care unit admissions
- Signed Informed Consent Form
Exclusion Criteria:
- Cyanotic congenital heart disease
- Not requiring mechanical ventilation
Sites / Locations
- Centenario Hospital Miguel HidalgoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ultrasound Guided Fluid Therapy
Conventional Fluid Therapy
Arm Description
Outcomes
Primary Outcome Measures
Length of stay
Number of days that the patient requires care in the ICU
Secondary Outcome Measures
Oxygenation Index
Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.
PaO2/FIO2
Ratio of arterial oxygen partial pressure to fractional inspired oxygen
Duration of mechanical ventilation
Days that a patient remains under mechanical ventilation
Full Information
NCT ID
NCT04215692
First Posted
December 27, 2019
Last Updated
March 11, 2023
Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Centenario Hospital Miguel Hidalgo
1. Study Identification
Unique Protocol Identification Number
NCT04215692
Brief Title
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
Official Title
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Centenario Hospital Miguel Hidalgo
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Overload Pulmonary Edema, Fluid Overload, Pneumonia, Ventilator-Associated, Fluid Overload Without Edema
Keywords
pediatric intensive care, lenght of stay
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Guided Fluid Therapy
Arm Type
Experimental
Arm Title
Conventional Fluid Therapy
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulmonary ultrasound
Intervention Description
Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.
Primary Outcome Measure Information:
Title
Length of stay
Description
Number of days that the patient requires care in the ICU
Time Frame
through study completion, an average of 14 days
Secondary Outcome Measure Information:
Title
Oxygenation Index
Description
Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.
Time Frame
Daily through study completion, an average of 14 days
Title
PaO2/FIO2
Description
Ratio of arterial oxygen partial pressure to fractional inspired oxygen
Time Frame
Daily through study completion, an average of 14 days
Title
Duration of mechanical ventilation
Description
Days that a patient remains under mechanical ventilation
Time Frame
through study completion, an average of 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All pediatric inpatient intensive care unit admissions
Signed Informed Consent Form
Exclusion Criteria:
Cyanotic congenital heart disease
Not requiring mechanical ventilation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maricela García-Arellano, MD
Phone
449 994 6720
Email
marigarcia8@yahoo.com
Facility Information:
Facility Name
Centenario Hospital Miguel Hidalgo
City
Aguascalientes
ZIP/Postal Code
20259
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan M Marquez-Romero, MD, MSc
Phone
4494548289
Email
scint1st@gmail.com
First Name & Middle Initial & Last Name & Degree
Maricela García-Arellano, MD
Phone
449 994 6720
Email
marigarcia8@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share the data.
Learn more about this trial
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
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