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

Completed

• Conditions: Healthy
• Interventions: Device: Jaeger Masterscreen TM; Device: HypAir Medisoft

• Registration Number: NCT04016597
• Lead Sponsor: University of Zurich

Brief Summary

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).

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 Timeline

• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-11
• Study Start: 2019-10-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung diffusing capacity measurements	HypAir Medisoft	Participants perform single-breath lung diffusing capacity measurements in random order during one study visit.
Lung diffusing capacity measurements	Jaeger Masterscreen TM	Participants perform single-breath lung diffusing capacity measurements in random order during one study visit.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Zurich and University Hospital of Zurich; 🇨🇭 Zurich, Switzerland