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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016597
• Other study ID #: 2019-00226
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Jaeger Masterscreen TM
Single-breath nitric oxide lung diffusing capacity
• HypAir Medisoft
Single-breath nitric oxide lung diffusing capacity

Locations

Country	Name	City	State
Switzerland	University of Zurich and University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Zavorsky GS, Hsia CC, Hughes JM, Borland CD, Guénard H, van der Lee I, Steenbruggen I, Naeije R, Cao J, Dinh-Xuan AT. Standardisation and application of the single-breath determination of nitric oxide uptake in the lung. Eur Respir J. 2017 Feb 8;49(2). pi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Difference in Alveolar volume (L)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in inspiratory volume (L)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in breath-hold time (s)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in inspired concentrations for helium (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in expired concentrations for helium (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 day
Secondary	Difference in inspired concentrations for oxygen (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in expired concentrations for oxygen (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour