Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults

February 10, 2020 updated by: University of Zurich

Comparison of Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults

The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices.

The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO).

  1. "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
  2. "HypAir" ("HA", Medisoft, Dinant, Belgium).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a single-center, crossover study conducted at the University Hospital Zurich, Switzerland, 35 healthy, non-smoking adults (>=18 years) will be invited to perform DLNO measurements in random order using the MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium) devices during one study visit.

The order of the tests on the MasterscreenTM and HypAir devices will be randomly allocated using central randomisation.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8001
        • University of Zurich and University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy people

Description

Inclusion Criteria:

- Age 18 years and older

Exclusion Criteria:

  • Previous thoracic surgery
  • Smoking
  • Chronic lung disease (e.g., asthma bronchiale, COPD)
  • Forced expiratory volume in 1s and/or forced vital capacity below the lower limit of normal based on spirometry [Quanjer et al. Eur Respir J 2005]
  • Current respiratory infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung diffusing capacity measurements
Participants perform single-breath lung diffusing capacity measurements in random order during one study visit.
Device: Jaeger Masterscreen TM
Single-breath nitric oxide lung diffusing capacity
Device: HypAir Medisoft
Single-breath nitric oxide lung diffusing capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in inspired concentrations for oxygen (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for oxygen (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for helium (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in Alveolar volume (L)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspiratory volume (L)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in breath-hold time (s)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for nitric oxide (in %)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for nitric oxide (in %)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for carbon monoxide (in %)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for carbon monoxide (in %)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for helium (%)
Time Frame: 1 day
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Thomas Radtke, PhD, University of Zurich, EBPI, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (ACTUAL)

July 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-00226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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