PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

University of Oulu

Status: Completed

Conditions: Neonatal Respiratory Distress

Treatments: Device: PNEUMACRIT

Study type: Interventional

Funder types: Other

Identifiers

NCT06171867

EETTMK: 73/2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12 hours to 6 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Feasibility of the PNEUMACRIT belt

Experimental group

Description:

Neonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback.

Treatment:

Device: PNEUMACRIT