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

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ClinicalTrials.gov Identifier: NCT02699268
Recruitment Status : Unknown
Verified February 2016 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment
Lung Disease Other: Lung function measurement

Detailed Description:

All infants will be assessed at the pediatric department at Haukeland University Hospital, and all data obtained by the same two investigators (Bentsen and Olsen). The infants will be dressed in the appropriate-sized vest selected according to the length from the armpit to the hip of the child. Care will be taken to ensure that the vest fits snugly around the torso and that the width of the copper wire zig-zag coveres the entire thorax and abdomen including the pubic region. The vest will be applied directly to the skin; neither body nor diaper will be worn underneath. The infants will then be fed before they will be placed supine in a cot and encouraged to sleep. No sedation will be used. Once the infant has fallen asleep, data will be collected with VSP for 2-3 minutes before the Exhalyzer D® neonatal facemask connected in series with the ultrasonic flow sensor will be placed gently, but firmly over the infant's mouth and nose, ensuring a good seal. Once the facemask is in place, a marker will be inserted in the VSP recording. The Exhalyzer D® measurement will be started about thirty seconds after the facemask has been put on, to allow adaptation to the facemask. Simultaneous recording using both devices will then be done for about 1 minute before the mask will be removed. New markers will be inserted in the VSP recording as the Exhalyzer D® measurement is started and stopped facilitating analysis of the same breathing cycles.

Data will be analysed and graphs will be created with SPSS version 22 (IBM SPSS Statistics, New York, US) and MedCalc version 13.1 (MedCalc Software, Mariakerke, Belgium). Bland-Altman plots will be used to visualize agreement between the two measurement techniques. For each pair of measurements, the pairwise mean of the breathing parameters will be plotted on the x-axis, and the pairwise difference expressed as a percentage of their mean value on the y-axis. The mean difference and the 95% limits of agreement and their confidence intervals will be represented by horizontal lines in the graphs.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of VoluSense Pediatrics, a New Method of Infant Spirometry Based on Electromagnetic Inductance Plethysmography
Study Start Date : December 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Tidal volume. Unit is milliliter [ Time Frame: 1 hour ]
    Tidal volume will be measured using the two Methods and compared using Bland-Altman statistics


Secondary Outcome Measures :
  1. Respiratory Rate. Unit is counts per minute [ Time Frame: 1 hour ]
    Respiratory rate will be measured using the two Methods and compared using Bland-Altman statistics

  2. Peak tidal expiratory flow (TPTEF). Unit is ml/sec [ Time Frame: 1 hour ]
    TPTEF will be measured using the two Methods and compared using Bland-Altman statistics

  3. the ratio of inspiratory to expiratory time (Ti/Te). This is a ratio, and thus no unit [ Time Frame: 1 hour ]
    Ti/Te will be measured using the two Methods and compared using Bland-Altman statistics

  4. The ratio of tidal expiratory flow at 50% of expired volume to peak tidal expiratory flow (TEF 50/PTEF). [ Time Frame: 1 hour ]
    TEF 50/PTEF will be measured using the two Methods and compared using Bland-Altman statistics

  5. Total expiratory time (Tptef/Te). This is a ratio, and thus no unit [ Time Frame: 1 hour ]
    Tptef/Te will be measured using the two Methods and compared using Bland-Altman statistics



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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Term born and preterm born babies ≥ 2000 grams.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699268


Contacts
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Contact: Mariann H Bentsen, MD +47 55970871 bens@helse-bergen.no
Contact: Thomas Halvorsen, MD +4755975300 thomas.halvorsen@helse-bergen.no

Locations
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Norway
Haukeland University Hospital, Pediatric department, NICU Recruiting
Bergen, Western Norway, Norway, 5021
Contact: Mariann H Bentsen, MD    +47 55970871    bens@helse-bergen.no   
Contact: Thomas Halvorsen, MD    +47 55975300    thomas.halvorsen@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
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Principal Investigator: Trond Markestad, MD Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02699268    
Other Study ID Numbers: REK Vest 2010/496-8
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases