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Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal

F

Fu Jen Catholic University

Status

Enrolling

Conditions

Bronchopulmonary Dysplasia

Treatments

Other: Pressure-Sensing Mattresses

Study type

Observational

Funder types

Other

Identifiers

NCT06579157
FJUH113387

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Ke-Yun Chao, PhD

Data sourced from clinicaltrials.gov

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