Back to resultsEffect of Nasal Highflow on Right Heart Function (HÄMOFLOW)
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nasal high flow (NHF) supplementation
oxygen supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring NHF, pulmonary hypertension
Eligibility Criteria
Inclusion Criteria:
- stable disease
- hypoxemic respiratory disorder
Exclusion Criteria:
- decompensation
- acute illness
Sites / Locations
- Department of Respiratory Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
oxygen supplementation
Nasal high flow (NHF) supplementation
Arm Description
right heart catheterization will be done in hypoxemic patients with supplemental oxygen
right heart catheterization after during NHF (20 min) use with 35 l/min
Outcomes
Primary Outcome Measures
changes in mean pulmonary pressure (PAPm)
measured in mmHg
Secondary Outcome Measures
changes in wedge pressure (PC)
mmHg
changes in cardiac index (CI)
l/min/qm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02885116
Brief Title
Effect of Nasal Highflow on Right Heart Function
Acronym
HÄMOFLOW
Official Title
Hemodynamic Effects of Nasal Highflow on Patients With Chronic Respiratory Insufficiency and Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 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
In this study effect of NHF on pulmonary thermodynamic parameters will studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
NHF, pulmonary hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxygen supplementation
Arm Type
Placebo Comparator
Arm Description
right heart catheterization will be done in hypoxemic patients with supplemental oxygen
Arm Title
Nasal high flow (NHF) supplementation
Arm Type
Active Comparator
Arm Description
right heart catheterization after during NHF (20 min) use with 35 l/min
Intervention Type
Device
Intervention Name(s)
Nasal high flow (NHF) supplementation
Intervention Description
use of NHF for 20 min/ 35 l/min, at the end of this period right heart catheterization
Intervention Type
Device
Intervention Name(s)
oxygen supplementation
Intervention Description
hypoxemic patients will use their normal oxygen supplementation durch right heart catheterization
Primary Outcome Measure Information:
Title
changes in mean pulmonary pressure (PAPm)
Description
measured in mmHg
Time Frame
20 min
Secondary Outcome Measure Information:
Title
changes in wedge pressure (PC)
Description
mmHg
Time Frame
20 min
Title
changes in cardiac index (CI)
Description
l/min/qm
Time Frame
20 min
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable disease
hypoxemic respiratory disorder
Exclusion Criteria:
decompensation
acute illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Wirtz, MD
Organizational Affiliation
Department of Respiratory Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Respiratory Medicine
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Nasal Highflow on Right Heart Function
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