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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06079151
Acronym
HighFlowHD
Enrollment
20
Registered
2023-10-12
Start date
2024-02-13
Completion date
2026-02-12
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

High-flow nasal cannula therapy, Hemodynamic monitoring, Echocardiography, right heart catheterization

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.

Interventions

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary

Sponsors

ADIR Association
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac outputDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 30 and 50 L/min

Secondary

MeasureTime frameDescription
Right atrial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic pulmonary arterial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
diastolic pulmonary arterial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
mean pulmonary arterial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
capillary wedge pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
pulmonary vascular resistanceDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
central venous oxygen saturationDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
heart rateDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic arterial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
cardiac outputDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
mean arterial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
systolic ejection volumeDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
respiratory rateDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
pulse oxygen saturationDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.During the intervention, at isotimeCardiac 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 isotimeConcordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
capillary wedge pressure measured by catheterization and echocardiography.During the intervention, at isotimeConcordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
right atrial pressure measured by catheterization and echocardiography.During the intervention, at isotimeConcordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
cardiac output measured by catheterization and echocardiography.During the intervention, at isotimeConcordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
diastolic arterial pressureDuring the intervention, at isotimeChanges measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

Countries

France

Contacts

Primary ContactElise ARTAUD-MACARI, MD
elise.artaud-macari@chu-rouen.fr+33 2 32 88 59 92
Backup ContactMaryline LEFORT, RT
mlefort@adir-hautenormandie.com+33 2 32 88 59 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026