NCT06171867

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 24, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 23, 2023

Last Update Submit

February 27, 2024

Conditions

Neonatal Respiratory Distress

Keywords

Electrical impedance tomography, neonate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Staff and parent questionnaires

    48 hours

Study Arms (1)

Feasibility of the PNEUMACRIT belt

EXPERIMENTAL

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.

Device: PNEUMACRIT

Interventions

PNEUMACRITDEVICE

Monitoring of breathing

Feasibility of the PNEUMACRIT belt

Eligibility Criteria

Age12 Hours - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Related Links

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal investigator, Associate professor of pediatrics

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 15, 2023

Study Start

November 24, 2023

Primary Completion

February 25, 2024

Study Completion

February 25, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)