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

NCT02699268 | Unknown

• 1 other identifier: REK Vest 2010/496-8
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Lung Disease

Outcome Measures

Primary Outcomes (1)

• Tidal volume. Unit is milliliter

  Tidal volume will be measured using the two Methods and compared using Bland-Altman statistics

  1 hour

Secondary Outcomes (5)

• Respiratory Rate. Unit is counts per minute

  1 hour

• Peak tidal expiratory flow (TPTEF). Unit is ml/sec

  1 hour

• the ratio of inspiratory to expiratory time (Ti/Te). This is a ratio, and thus no unit

  1 hour

• The ratio of tidal expiratory flow at 50% of expired volume to peak tidal expiratory flow (TEF 50/PTEF).

  1 hour

• Total expiratory time (Tptef/Te). This is a ratio, and thus no unit

  1 hour

Study Arms (1)

Infants (term borns and preterm borns)

Intervention: simultaneous lung function measurement using VoluSense Pediatrics and a mask-based method with an ultrasonic flowmeter (EcoMedics Exhalyzer)

Other: Lung function measurement

Interventions

Lung function measurement OTHER

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

Infants (term borns and preterm borns)

Eligibility Criteria

• Age: 2 Days - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Term born and preterm born babies ≥ 2000 grams.

You may qualify if:

• Healthy term born or preterm born babies ≥ 2000 grams.

You may not qualify if:

• Being in an unstable clinical condition.
• Weight \< 2000 grams.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital, Pediatric department, NICU

Bergen, Western Norway, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Trond Markestad, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariann H Bentsen, MD

CONTACT

+47 55970871; bens@helse-bergen.no

Thomas Halvorsen, MD

CONTACT

+4755975300; thomas.halvorsen@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: March 4, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)