Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension (HighFlowHD)

April 18, 2024 updated by: ADIR Association

Physiological Evaluation of the Hemodynamic Effects of Nasal High Flow in Patients Being Explored by Right Heart Catheterisation and Echocardiography for Suspected or Followed Precapillary Pulmonary Hypertension

In this study, the investigators aim to describe the hemodynamic consequences of nasal high-flow measured during right heart catheterization and echocardiography. The research hypothesis is that nasal high-flow would increase cardiac output in patients with pulmonary hypertension. The concomitant echocardiography will allow to describe its sensibility to detect cardiovascular consequences of nasal high-flow.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.

Exclusion Criteria:

  • necessity of FiO2 >21% during right heart catheterization
  • intracardiac shunt
  • grade 4 tricuspid insufficiency
  • complete arrhythmia due to atrial fibrillation
  • Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
  • protected adult patient (tutorship or curatorship)
  • patient deprived of liberty by court or administrative decision
  • refusal of patient participation or consent
  • patient for whom the measurement of pulmonary arterial pressures during right heart catheterization is impossible
  • patient for whom, during the etiological assessment of pulmonary hypertension, the diagnosis of precapillary pulmonary hypertension cannot be confirmed and classified in groups 1, 3 or 4.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nasal high-flow 30 L/min and then 50 L/min
The patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 min.
Device: Nasal high-flow
Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary
Experimental: Nasal high-flow 50 L/min and then 30 L/min
The patient will be placed successively under nasal high-flow 50 L/min during 20 min and then 30 L/min during 20 min.
Device: Nasal high-flow
Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac output
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cardiac output
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
cardiac output
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
Right atrial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
Right atrial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
Right atrial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
systolic pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
systolic pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
systolic pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
diastolic pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
diastolic pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
diastolic pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
mean pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
mean pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
mean pulmonary arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
capillary wedge pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
capillary wedge pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
capillary wedge pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
pulmonary vascular resistance
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
pulmonary vascular resistance
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
pulmonary vascular resistance
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
central venous oxygen saturation
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
central venous oxygen saturation
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
central venous oxygen saturation
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
heart rate
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
heart rate
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
heart rate
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
systolic arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
systolic arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
systolic arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
diastolic arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
diastolic arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
diastolic arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
mean arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
mean arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
mean arterial pressure
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
systolic ejection volume
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
systolic ejection volume
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
systolic ejection volume
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
respiratory rate
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
respiratory rate
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
respiratory rate
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
pulse oxygen saturation
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
During the intervention, at isotime
pulse oxygen saturation
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
During the intervention, at isotime
pulse oxygen saturation
Time Frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
During the intervention, at isotime
Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.
Time Frame: During the intervention, at isotime
Cardiac output, inferior vena cava diameter and collapsibiliy, systolic pulmoanry arterial pressure, tricuspid regurgitation velocity,tricuspid annular plane systolic excursion, right ventricule strain, tricuspid S wave, right on left ventricular telediastolic surface ratio, left ventricular ejection fraction, mitral doppler, mitral S wave, respiratory variability of E mitral wave
During the intervention, at isotime
systolic pulmonary arterial pressure measured by catheterization and echocardiography.
Time Frame: During the intervention, at isotime
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
During the intervention, at isotime
capillary wedge pressure measured by catheterization and echocardiography.
Time Frame: During the intervention, at isotime
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
During the intervention, at isotime
right atrial pressure measured by catheterization and echocardiography.
Time Frame: During the intervention, at isotime
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
During the intervention, at isotime
cardiac output measured by catheterization and echocardiography.
Time Frame: During the intervention, at isotime
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
During the intervention, at isotime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ADIR Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elise ARTAUD-MACARI, MD, ADIR Association

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HighFlowHD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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