Back to resultsHemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension (HighFlowHD)
Primary Purpose
Pulmonary Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nasal high-flow
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring High-flow nasal cannula therapy, Hemodynamic monitoring, Echocardiography, right heart catheterization
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nasal high-flow 30 L/min and then 50 L/min
Nasal high-flow 50 L/min and then 30 L/min
Arm Description
The patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 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.
Outcomes
Primary Outcome Measures
Cardiac output
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Secondary Outcome Measures
cardiac output
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
cardiac output
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Right atrial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Right atrial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Right atrial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
systolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
systolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
diastolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
diastolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
diastolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
mean pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
mean pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
mean pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
capillary wedge pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
capillary wedge pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
capillary wedge pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
pulmonary vascular resistance
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
pulmonary vascular resistance
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
pulmonary vascular resistance
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
central venous oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
central venous oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
central venous oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
heart rate
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
heart rate
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
heart rate
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
systolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
systolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
diastolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
diastolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
diastolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
mean arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
mean arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
mean arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
systolic ejection volume
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic ejection volume
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
systolic ejection volume
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
respiratory rate
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
respiratory rate
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
respiratory rate
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
pulse oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
pulse oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
pulse oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.
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
systolic pulmonary arterial pressure measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
capillary wedge pressure measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
right atrial pressure measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
cardiac output measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06079151
Brief Title
Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension
Acronym
HighFlowHD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADIR Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
High-flow nasal cannula therapy, Hemodynamic monitoring, Echocardiography, right heart catheterization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All patients will be randomly allocated into two groups using the block randomization technique (4 or 8 according to an equiprobable distribution) in a 1:1 ratio. The randomisation will be performed at the begining of the catheterization procedure. In the first arm, the patient will successively receive 30 L/min then 50 L/min of room air. In the second arm, the patient will successively receive 50 L/min then 30 L/min of room air.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal high-flow 30 L/min and then 50 L/min
Arm Type
Experimental
Arm Description
The patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 min.
Arm Title
Nasal high-flow 50 L/min and then 30 L/min
Arm Type
Experimental
Arm Description
The patient will be placed successively under nasal high-flow 50 L/min during 20 min and then 30 L/min during 20 min.
Intervention Type
Device
Intervention Name(s)
Nasal high-flow
Intervention Description
Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary
Primary Outcome Measure Information:
Title
Cardiac output
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Secondary Outcome Measure Information:
Title
cardiac output
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
cardiac output
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
Right atrial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
Right atrial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
Right atrial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
systolic pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
systolic pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
systolic pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
diastolic pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
diastolic pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
diastolic pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
mean pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
mean pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
mean pulmonary arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
capillary wedge pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
capillary wedge pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
capillary wedge pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
pulmonary vascular resistance
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
pulmonary vascular resistance
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
pulmonary vascular resistance
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
central venous oxygen saturation
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
central venous oxygen saturation
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
central venous oxygen saturation
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
heart rate
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
heart rate
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
heart rate
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
systolic arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
systolic arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
systolic arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
diastolic arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
diastolic arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
diastolic arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
mean arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
mean arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
mean arterial pressure
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
systolic ejection volume
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
systolic ejection volume
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
systolic ejection volume
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
respiratory rate
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
respiratory rate
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
respiratory rate
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
pulse oxygen saturation
Description
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
pulse oxygen saturation
Description
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Time Frame
During the intervention, at isotime
Title
pulse oxygen saturation
Description
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Time Frame
During the intervention, at isotime
Title
Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.
Description
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
Time Frame
During the intervention, at isotime
Title
systolic pulmonary arterial pressure measured by catheterization and echocardiography.
Description
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Time Frame
During the intervention, at isotime
Title
capillary wedge pressure measured by catheterization and echocardiography.
Description
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Time Frame
During the intervention, at isotime
Title
right atrial pressure measured by catheterization and echocardiography.
Description
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Time Frame
During the intervention, at isotime
Title
cardiac output measured by catheterization and echocardiography.
Description
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Time Frame
During the intervention, at isotime
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise ARTAUD-MACARI, MD
Phone
+33 2 32 88 59 92
Email
elise.artaud-macari@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maryline LEFORT, RT
Phone
+33 2 32 88 59 92
Email
mlefort@adir-hautenormandie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise ARTAUD-MACARI, MD
Organizational Affiliation
ADIR Association
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension
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