NCT02885116

Brief Summary

In this study effect of NHF on pulmonary thermodynamic parameters will studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

August 22, 2016

Last Update Submit

June 21, 2018

Conditions

Pulmonary Hypertension

Keywords

NHFpulmonary hypertension

Outcome Measures

Primary Outcomes (1)

  • changes in mean pulmonary pressure (PAPm)

    measured in mmHg

    20 min

Secondary Outcomes (2)

  • changes in wedge pressure (PC)

    20 min

  • changes in cardiac index (CI)

    20 min

Study Arms (2)

oxygen supplementation

PLACEBO COMPARATOR

right heart catheterization will be done in hypoxemic patients with supplemental oxygen

Device: oxygen supplementation

Nasal high flow (NHF) supplementation

ACTIVE COMPARATOR

right heart catheterization after during NHF (20 min) use with 35 l/min

Device: Nasal high flow (NHF) supplementation

Interventions

Nasal high flow (NHF) supplementationDEVICE

use of NHF for 20 min/ 35 l/min, at the end of this period right heart catheterization

Nasal high flow (NHF) supplementation
oxygen supplementationDEVICE

hypoxemic patients will use their normal oxygen supplementation durch right heart catheterization

oxygen supplementation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stable disease
  • hypoxemic respiratory disorder

You may not qualify if:

  • decompensation
  • acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiratory Medicine

Leipzig, Saxony, 04103, Germany

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Hubert Wirtz, MD

    Department of Respiratory Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 31, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

DE(1)