Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pressure-Sensing Mattresses.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia. Basic parameters: up to 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Association Between Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
Overview
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.
Interventions
- Other Pressure-Sensing Mattresses
using ballistocardiography (BCG) for monitoring respiration and heart rate in neonates
Primary outcome measures
- ballistocardiography waveform [Time frame: through study completion, an average of 2 weeks]
Secondary outcome measures (1)
- tidal volume [Time frame: through study completion, an average of 2 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City
Identifiers
NCT: NCT06579157 · FJUH113387