Clinical trial NCT04016597: Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults
Official title: Comparison of Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: diffusing capacity
reliability
healthy
adults
nitric oxide
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy people

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)
timeFrame: 1 hour
Secondary outcomes:
measure: Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)
timeFrame: 1 hour
measure: Difference in Alveolar volume (L)
timeFrame: 1 hour
measure: Difference in inspiratory volume (L)
timeFrame: 1 hour
measure: Difference in breath-hold time (s)
timeFrame: 1 hour
measure: Difference in inspired concentrations for nitric oxide (in %)
timeFrame: 1 hour
measure: Difference in expired concentrations for nitric oxide (in %)
timeFrame: 1 hour
measure: Difference in inspired concentrations for carbon monoxide (in %)
timeFrame: 1 hour
measure: Difference in expired concentrations for carbon monoxide (in %)
timeFrame: 1 hour
measure: Difference in inspired concentrations for helium (%)
timeFrame: 1 hour
measure: Difference in expired concentrations for helium (%)
timeFrame: 1 day
measure: Difference in inspired concentrations for oxygen (%)
timeFrame: 1 hour
measure: Difference in expired concentrations for oxygen (%)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich and University Hospital of Zurich
Study officials:
affiliation: University of Zurich, EBPI, Switzerland
name: Thomas Radtke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zavorsky GS, Hsia CC, Hughes JM, Borland CD, Guenard 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):1600962. doi: 10.1183/13993003.00962-2016. Print 2017 Feb.