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

Sponsor

ADIR Association (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06079151

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Device: Nasal high-flow	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Cardiac output [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min

Secondary Outcome Measures

cardiac output [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
cardiac output [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Right atrial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Right atrial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Right atrial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
systolic pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
systolic pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
diastolic pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
diastolic pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
diastolic pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
mean pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
mean pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
mean pulmonary arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
capillary wedge pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
capillary wedge pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
capillary wedge pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
pulmonary vascular resistance [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
pulmonary vascular resistance [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
pulmonary vascular resistance [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
central venous oxygen saturation [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
central venous oxygen saturation [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
central venous oxygen saturation [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
heart rate [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
heart rate [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
heart rate [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
systolic arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
systolic arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
diastolic arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
diastolic arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
diastolic arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
mean arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
mean arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
mean arterial pressure [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
systolic ejection volume [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic ejection volume [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
systolic ejection volume [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
respiratory rate [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
respiratory rate [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
respiratory rate [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
pulse oxygen saturation [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
pulse oxygen saturation [During the intervention, at isotime]
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
pulse oxygen saturation [During the intervention, at isotime]
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. [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
systolic pulmonary arterial pressure measured by catheterization and echocardiography. [During the intervention, at isotime]
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
capillary wedge pressure measured by catheterization and echocardiography. [During the intervention, at isotime]
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
right atrial pressure measured by catheterization and echocardiography. [During the intervention, at isotime]
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
cardiac output measured by catheterization and echocardiography. [During the intervention, at isotime]
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.