Effect of Nasal Highflow on Right Heart Function (HÄMOFLOW)
June 21, 2018 updated by: Jens Bräunlich, MD, University of Leipzig
Hemodynamic Effects of Nasal Highflow on Patients With Chronic Respiratory Insufficiency and Pulmonary Hypertension
In this study effect of NHF on pulmonary thermodynamic parameters will studied.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Sachsen
-
Leipzig, Sachsen, Germany, 04103
- Department of Respiratory Medicine
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- stable disease
- hypoxemic respiratory disorder
Exclusion Criteria:
- decompensation
- acute illness
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: oxygen supplementation
right heart catheterization will be done in hypoxemic patients with supplemental oxygen
|
hypoxemic patients will use their normal oxygen supplementation durch right heart catheterization
|
|
ACTIVE_COMPARATOR: Nasal high flow (NHF) supplementation
right heart catheterization after during NHF (20 min) use with 35 l/min
|
use of NHF for 20 min/ 35 l/min, at the end of this period right heart catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in mean pulmonary pressure (PAPm)
Time Frame: 20 min
|
measured in mmHg
|
20 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in wedge pressure (PC)
Time Frame: 20 min
|
mmHg
|
20 min
|
|
changes in cardiac index (CI)
Time Frame: 20 min
|
l/min/qm
|
20 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hubert Wirtz, MD, Department of Respiratory Medicine
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
January 1, 2016
Primary Completion (ACTUAL)
February 1, 2018
Study Completion (ACTUAL)
February 1, 2018
Study Registration Dates
First Submitted
August 22, 2016
First Submitted That Met QC Criteria
August 25, 2016
First Posted (ESTIMATE)
August 31, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 461-15-24082015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.