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

Pulmonary Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079151
• Other study ID #: HighFlowHD
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: February 12, 2026

Study information

• Verified date: April 2024
• Source: ADIR Association
• Contact: Elise ARTAUD-MACARI, MD
• Phone: +33 2 32 88 59 92
• Email: elise.artaud-macari[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 12, 2026
• Est. primary completion date: February 12, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
France	ROUEN university hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

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