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

Lung Disease Clinical Trial

Official title:

Validation of VoluSense Pediatrics, a New Method of Infant Spirometry Based on Electromagnetic Inductance Plethysmography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02699268
• Other study ID #: REK Vest 2010/496-8
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2015
• Last updated: February 29, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Haukeland University Hospital
• Contact: Mariann H Bentsen, MD
• Phone: +47 55970871
• Email: bens[@]helse-bergen.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Being in an unstable clinical condition.

• Weight < 2000 grams.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Pediatric department, NICU	Bergen	Western Norway

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal volume. Unit is milliliter	Tidal volume will be measured using the two Methods and compared using Bland-Altman statistics	1 hour	No
Secondary	Respiratory Rate. Unit is counts per minute	Respiratory rate will be measured using the two Methods and compared using Bland-Altman statistics	1 hour	Yes
Secondary	Peak tidal expiratory flow (TPTEF). Unit is ml/sec	TPTEF will be measured using the two Methods and compared using Bland-Altman statistics	1 hour	No
Secondary	the ratio of inspiratory to expiratory time (Ti/Te). This is a ratio, and thus no unit	Ti/Te will be measured using the two Methods and compared using Bland-Altman statistics	1 hour	No
Secondary	The ratio of tidal expiratory flow at 50% of expired volume to peak tidal expiratory flow (TEF 50/PTEF).	TEF 50/PTEF will be measured using the two Methods and compared using Bland-Altman statistics	1 hour	No
Secondary	Total expiratory time (Tptef/Te). This is a ratio, and thus no unit	Tptef/Te will be measured using the two Methods and compared using Bland-Altman statistics	1 hour	No