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NCT06171867 Clinical Trial

PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

Neonatal Respiratory Distress Clinical Trial

— PNEUMACRIT  

Official title:
Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06171867
Other study ID # EETTMK: 73/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date February 25, 2024

Study information
Verified date February 2024
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.

Description:

Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 25, 2024
Est. primary completion date February 25, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Hours to 6 Months
Eligibility Inclusion Criteria: - Inpatient at Oulu University Hospital PICU or NICU - Gestational age at birth over 32 weeks - Weight 2000-5000g - Postnatal age > 12 hours - Written informed consent from the parents of legal representative - Non-invasive monitoring of oxygen saturation and ECG Exclusion Criteria: - Postmenstrual age < 32 weeks - Weight at time of the study < 2000g or > 5000g - Chest skin lesion preventing safe use of the electrode belt - Recent chest surgery within the past 7 days (e.g. thoracotomy)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PNEUMACRIT
Monitoring of breathing

Locations
Country Name City State
Finland Oulu University Hospital Oulu

Sponsors (2)
Lead Sponsor Collaborator
University of Oulu Middlesex University

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion (%) of recording time with high quality EIT-signal Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration 6-24 hours
Secondary Staff and parent questionnaires After the study period, the patient parents and nurses will give feedback on the device and its feasibility with a structured questionnaire including also free text fields 48 hours
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