Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults

Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults: a Comparison of Two Commercially Available Devices

This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Study Overview

• Status: Completed
• Conditions: Healthy; Cystic Fibrosis
• Intervention / Treatment: Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"

Detailed Description

Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CF : primary care clinic HC : community sample

Description

Inclusion Criteria:

• Cystic fibrosis diagnosis

Exclusion Criteria:

• Respiratory infection within 3 weeks
• Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cystic fibrosis adults (CF); No treatment, comparison of LCI values obtained with two devices	Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"; Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.
Healthy adults (HC); No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system.	Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"; Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung Clearance Index (LCI)	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)	Difference in discriminative ability between devices will be assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device	1 hour
Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)	FRC will be compared with a third device in a subset of 11 healthy adults : the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's preference	Just after the completion of the tests, subjects will be asked to answer which one of the device they most preferred (i.e.: device A or device B or no preference).	1 hour

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Study Director: Patrick Lebecque, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain; Principal Investigator: William Poncin, PhD student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain; Study Chair: Anne-Sophie Aubriot, PhD student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Lung Clearance Index; Multiple Breath Nitrogen Washout
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: StLuc MBWN2 01