Back to resultsPhysiological and Clinical Changes in NHF Therapy (ATMOFLOW)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Hypercapnia, Interstitital Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nasal Highflow (NHF)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring nasal high flow
Eligibility Criteria
Inclusion Criteria:
- COPD, ILD
Exclusion Criteria:
- Unstable disease
Sites / Locations
- Jens Bräunlich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ventilatory effects
Arm Description
measuring mean airway pressure, breathing volumes and decrease in hypercapnia
Outcomes
Primary Outcome Measures
changes in mean airway pressure (mbar)
changes in tidal and minute volume (l)
changes in breathing frequency (beats/ minute)
Secondary Outcome Measures
changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504814
Brief Title
Physiological and Clinical Changes in NHF Therapy
Acronym
ATMOFLOW
Official Title
Physiological and Clinical Changes in NHF Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypercapnia, Interstitital Lung Disease
Keywords
nasal high flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ventilatory effects
Arm Type
Experimental
Arm Description
measuring mean airway pressure, breathing volumes and decrease in hypercapnia
Intervention Type
Device
Intervention Name(s)
Nasal Highflow (NHF)
Other Intervention Name(s)
TNI softflow50
Intervention Description
changes in breathing physiology in NHF
Primary Outcome Measure Information:
Title
changes in mean airway pressure (mbar)
Time Frame
1 month
Title
changes in tidal and minute volume (l)
Time Frame
1 month
Title
changes in breathing frequency (beats/ minute)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD, ILD
Exclusion Criteria:
Unstable disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Bräunlich, MD
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
Facility Information:
Facility Name
Jens Bräunlich
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29368599
Citation
Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
Results Reference
derived
Learn more about this trial
Physiological and Clinical Changes in NHF Therapy
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