Pulmonary HypertensionHÄMOFLOWNCT02885116
Effect of Nasal Highflow on Right Heart Function
A study testing Nasal high flow (NHF) supplementation and oxygen supplementation in people with Pulmonary Hypertension, run by University of Leipzig at 1 site in Germany.
Trial summary
In this study effect of NHF on pulmonary thermodynamic parameters will studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Nasal high flow (NHF) supplementation and oxygen supplementation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stable disease
- hypoxemic respiratory disorder
Who cannot join
- decompensation
- acute illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Nasal high flow (NHF) supplementation, oxygen supplementation
- Keywords
- NHF, pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flow (NHF) supplementationDevice
use of NHF for 20 min/ 35 l/min, at the end of this period right heart catheterization
oxygen supplementationDevice
hypoxemic patients will use their normal oxygen supplementation durch right heart catheterization
| Study group | Role | What they receive |
|---|---|---|
| oxygen supplementation | Placebo comparator | right heart catheterization will be done in hypoxemic patients with supplemental oxygen Receives: Device: oxygen supplementation |
| Nasal high flow (NHF) supplementation | Active comparator | right heart catheterization after during NHF (20 min) use with 35 l/min Receives: Device: Nasal high flow (NHF) supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in mean pulmonary pressure (PAPm)
measured in mmHg
Measured: 20 min
Secondary outcomes (2)
changes in wedge pressure (PC)
mmHg
Measured: 20 min
changes in cardiac index (CI)
l/min/qm
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Bräunlich, MD, University of Leipzig
- Investigators
- Hubert Wirtz, MD, Study director, Department of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885116
- Sponsor's protocol ID
- 461-15-24082015
- Acronym
- HÄMOFLOW
- Status last verified
- Jun 2018
- First submitted
- 22 Aug 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Nasal Highflow on Patients With Chronic Respiratory Insufficiency and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02885116
- Acronym / sponsor ID
- HÄMOFLOW / 461-15-24082015
- Conditions
- Pulmonary Hypertension
- Keywords
- NHF, pulmonary hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study effect of NHF on pulmonary thermodynamic parameters will studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen supplementation | Placebo comparator | Device: oxygen supplementationright heart catheterization will be done in hypoxemic patients with supplemental oxygen |
| Nasal high flow (NHF) supplementation | Active comparator | Device: Nasal high flow (NHF) supplementationright heart catheterization after during NHF (20 min) use with 35 l/min |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- stable disease
- hypoxemic respiratory disorder
Key exclusion criteria (2 listed)
- decompensation
- acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal high flow (NHF) supplementationuse of NHF for 20 min/ 35 l/min, at the end of this period right heart catheterization | Device | Nasal high flow (NHF) supplementation |
| oxygen supplementationhypoxemic patients will use their normal oxygen supplementation durch right heart catheterization | Device | oxygen supplementation |
Primary outcome
changes in mean pulmonary pressure (PAPm)
Time frame: 20 min
measured in mmHg
2 secondary outcomes
changes in wedge pressure (PC)
Time frame: 20 min
changes in cardiac index (CI)
Time frame: 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Wirtz, MD study director
Department of Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high flow (NHF) supplementation and oxygen supplementation in people with Pulmonary Hypertension, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in mean pulmonary pressure (PAPm) (time frame: 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.