MedTrace Logo

A Clinical Study Aiming to Validate the Equipment: VoluSense Pediatrics (VSP)

NCT02699268 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2016-03-04

No results posted yet for this study

Summary

This is a cross-sectional observational study, aiming to validate the accuracy of tidal breathing measurements in infants made by VoluSense Pediatrics, a lung function method based on electromagnetic inductance plethysmography, compared to an ultrasonic flowmeter. VoluSense Pediatrics consists of a flexible vest placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment. The equipment is made by VoluSense Norway AS, and is owned by Haukeland University Hospital.

Conditions

Interventions

OTHER

Lung function measurement

The infants will be exposed to lung function measurements performed by a new metod (Volusense Pediatrics) and a validated method (EcoMedics Exhalyzer D). The two Methods will be compared. This is not an intervential study, but a study aiming to validate a New Method versus an old method

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Trond Markestad, MD · Haukeland University Hospital

Eligibility

Min Age
2 Days
Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699268 on ClinicalTrials.gov