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

NCT ID: NCT04016597

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung diffusing capacity measurements

Participants perform single-breath lung diffusing capacity measurements in random order during one study visit.

Jaeger Masterscreen TM

Intervention Type DEVICE

Single-breath nitric oxide lung diffusing capacity

HypAir Medisoft

Intervention Type DEVICE

Single-breath nitric oxide lung diffusing capacity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Jaeger Masterscreen TM

Single-breath nitric oxide lung diffusing capacity

Intervention Type DEVICE

HypAir Medisoft

Single-breath nitric oxide lung diffusing capacity

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Radtke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, EBPI, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Zurich and University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28179436 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-00226

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.