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

  • Germany
    • 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
Device: oxygen supplementation
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
Device: Nasal high flow (NHF) supplementation
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

University of Leipzig

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.

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