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Clinical Trials/NCT06579157
NCT06579157
Recruiting
Not Applicable

The Association Between Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal

Fu Jen Catholic University1 site in 1 country60 target enrollmentNovember 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchopulmonary Dysplasia
Sponsor
Fu Jen Catholic University
Enrollment
60
Locations
1
Primary Endpoint
ballistocardiography waveform
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

Detailed Description

Background: Traditional physiological measurement methods often require subjects to remain immobile or have various devices attached to their bodies, causing discomfort, especially unsuitable for neonatal care. However, with the development of electronic technologies, these methods have improved. ballistocardiography (BCG) presents a possible solution for monitoring neonates' physiological signals. BCG is a non-invasive and non-contact instrument that measures the body's reactive motion pressure changes caused by cardiac contraction. These sensors do not require direct attachment, allowing for long-term physiological signal measurement without disturbing the subject. Methods: The study will be conducted in the neonatal intensive care unit on the seventh floor of Fu Jen Catholic University Hospital, with an expected enrollment of 60 participants. The subjects will be grouped and stratified based on weight and the use of invasive respiratory support. During the hospitalization, daily output of ventilator data and physiological monitor data will be collected and analyzed for correlation. Effect: This trial is expected to confirm the application of BCG in the neonatal population, demonstrate its correlation with current conventional physiological monitors, and assess its applicability in low-weight preterm infants. Additionally, the study will investigate whether continuous BCG monitoring during hospitalization can predict the possibility of bronchopulmonary dysplasia.

Registry
clinicaltrials.gov
Start Date
November 10, 2024
End Date
February 28, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

Eligibility Criteria

Inclusion Criteria

  • Using invasive ventilation support with flow sensors or non-invasive ventilation support
  • The legal representative signs the informed consent form

Exclusion Criteria

  • Refusal to participate in the study

Outcomes

Primary Outcomes

ballistocardiography waveform

Time Frame: through study completion, an average of 2 weeks

the correlation between using Ballistocardiography (BCG) for monitoring respiration and heart rate

Secondary Outcomes

  • tidal volume(through study completion, an average of 2 weeks)

Study Sites (1)

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