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

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: Recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Device: Nasal high-flow

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elise ARTAUD-MACARI, MD; Phone Number: +33 2 32 88 59 92; Email: elise.artaud-macari@chu-rouen.fr
• Study Contact Backup: Name: Maryline LEFORT, RT; Phone Number: +33 2 32 88 59 92; Email: mlefort@adir-hautenormandie.com

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Rouen University Hospital
    • Contact: Elise Artaud-Macari, MD; Email: eliseartaudmacari@yahoo.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ADIR Association
• Investigators: Principal Investigator: Elise ARTAUD-MACARI, MD, ADIR Association

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): February 12, 2026
• Study Completion (Estimated): February 12, 2026

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography; Hemodynamic monitoring; right heart catheterization; High-flow nasal cannula therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID 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