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

Study Overview
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Brief Summary
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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). MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany HypAir (HA, Medisoft, Dinant, Belgium).

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Jaeger Masterscreen TM
* Device: HypAir Medisoft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diffusing capacity, reliability, healthy, adults, nitric oxide