PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

University of Oulu20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Neonatal Respiratory Distress

Interventions

PNEUMACRITDEVICE

Monitoring of breathing

Eligibility

Sex: ALLMin age: 12 HoursMax age: 6 Months

Medical Language ↔ Plain English

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)

Locations (1)

Oulu University Hospital

Oulu, Finland

Outcomes

Primary Outcomes

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

Time frame: 6-24 hours

Secondary Outcomes

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

Time frame: 48 hours

Data from ClinicalTrials.gov

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