Physiological and Clinical Changes in NHF Therapy (ATMOFLOW)

February 14, 2019 updated by: Jens Bräunlich, MD, University of Leipzig
The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Jens Bräunlich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD, ILD

Exclusion Criteria:

  • Unstable disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ventilatory effects
measuring mean airway pressure, breathing volumes and decrease in hypercapnia
Device: Nasal Highflow (NHF)
changes in breathing physiology in NHF
Other Names:
  • TNI softflow50

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in mean airway pressure (mbar)
Time Frame: 1 month
1 month
changes in tidal and minute volume (l)
Time Frame: 1 month
1 month
changes in breathing frequency (beats/ minute)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)
Time Frame: 4 month
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Study Director: Jens Bräunlich, MD, University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 414-14-06102014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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