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Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal

NCT ID: NCT06579157

Last Updated: 2024-11-20

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

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-10

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pressure-Sensing Mattresses

using ballistocardiography (BCG) for monitoring respiration and heart rate in neonates

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ke-Yun Chao, PhD

Role: CONTACT

[email protected]
+886905301879

Facility Contacts

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Ke-Yun Chao, PhD

Role: primary

[email protected]
+886-905-301-879

Other Identifiers

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FJUH113387

Identifier Type: -

Identifier Source: org_study_id

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