PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

Not Applicable

Completed

• Conditions: Neonatal Respiratory Distress
• Interventions: Device: PNEUMACRIT

• Registration Number: NCT06171867
• Lead Sponsor: University of Oulu

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-23
• Study Start: 2023-11-24
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-15
• Status Verified: 2024-02
• Primary Completion: 2024-02-25
• Study Completion: 2024-02-25
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility of the PNEUMACRIT belt	PNEUMACRIT	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.

Primary Outcome Measures

Name	Time	Method
Proportion (%) of recording time with high quality EIT-signal	6-24 hours	Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration

Secondary Outcome Measures

Name	Time	Method
Staff and parent questionnaires	48 hours	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

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland