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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Device: Nasal high-flow


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal high-flow 30 L/min and then 50 L/min<br>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<br>* Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary<br>|
| Experimental: Nasal high-flow 50 L/min and then 30 L/min<br>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<br>* Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output | 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 | 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 | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| systolic pulmonary arterial pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| diastolic pulmonary arterial pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| mean pulmonary arterial pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| capillary wedge pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| pulmonary vascular resistance | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| central venous oxygen saturation | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| heart rate | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| systolic arterial pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| diastolic arterial pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| mean arterial pressure | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| systolic ejection volume | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| respiratory rate | 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 | 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 | Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min | During the intervention, at isotime | 
| pulse oxygen saturation | 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 | 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 | 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. | 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. | Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography. | During the intervention, at isotime | 
| capillary wedge pressure measured by catheterization and echocardiography. | Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography. | During the intervention, at isotime | 
| right atrial pressure measured by catheterization and echocardiography. | Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography. | During the intervention, at isotime | 
| cardiac output measured by catheterization and echocardiography. | Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography. | During the intervention, at isotime | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-flow nasal cannula therapy, Hemodynamic monitoring, Echocardiography, right heart catheterization