Clinical trial NCT06079151: Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: High-flow nasal cannula therapy
Hemodynamic monitoring
Echocardiography
right heart catheterization
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac output
timeFrame: During the intervention, at isotime
Secondary outcomes:
measure: cardiac output
timeFrame: During the intervention, at isotime
measure: cardiac output
timeFrame: During the intervention, at isotime
measure: Right atrial pressure
timeFrame: During the intervention, at isotime
measure: Right atrial pressure
timeFrame: During the intervention, at isotime
measure: Right atrial pressure
timeFrame: During the intervention, at isotime
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: diastolic pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: diastolic pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: diastolic pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: mean pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: mean pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: mean pulmonary arterial pressure
timeFrame: During the intervention, at isotime
measure: capillary wedge pressure
timeFrame: During the intervention, at isotime
measure: capillary wedge pressure
timeFrame: During the intervention, at isotime
measure: capillary wedge pressure
timeFrame: During the intervention, at isotime
measure: pulmonary vascular resistance
timeFrame: During the intervention, at isotime
measure: pulmonary vascular resistance
timeFrame: During the intervention, at isotime
measure: pulmonary vascular resistance
timeFrame: During the intervention, at isotime
measure: central venous oxygen saturation
timeFrame: During the intervention, at isotime
measure: central venous oxygen saturation
timeFrame: During the intervention, at isotime
measure: central venous oxygen saturation
timeFrame: During the intervention, at isotime
measure: heart rate
timeFrame: During the intervention, at isotime
measure: heart rate
timeFrame: During the intervention, at isotime
measure: heart rate
timeFrame: During the intervention, at isotime
measure: systolic arterial pressure
timeFrame: During the intervention, at isotime
measure: systolic arterial pressure
timeFrame: During the intervention, at isotime
measure: systolic arterial pressure
timeFrame: During the intervention, at isotime
measure: diastolic arterial pressure
timeFrame: During the intervention, at isotime
measure: diastolic arterial pressure
timeFrame: During the intervention, at isotime
measure: diastolic arterial pressure
timeFrame: During the intervention, at isotime
measure: mean arterial pressure
timeFrame: During the intervention, at isotime
measure: mean arterial pressure
timeFrame: During the intervention, at isotime
measure: mean arterial pressure
timeFrame: During the intervention, at isotime
measure: systolic ejection volume
timeFrame: During the intervention, at isotime
measure: systolic ejection volume
timeFrame: During the intervention, at isotime
measure: systolic ejection volume
timeFrame: During the intervention, at isotime
measure: respiratory rate
timeFrame: During the intervention, at isotime
measure: respiratory rate
timeFrame: During the intervention, at isotime
measure: respiratory rate
timeFrame: During the intervention, at isotime
measure: pulse oxygen saturation
timeFrame: During the intervention, at isotime
measure: pulse oxygen saturation
timeFrame: During the intervention, at isotime
measure: pulse oxygen saturation
timeFrame: During the intervention, at isotime
measure: Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.
timeFrame: During the intervention, at isotime
measure: systolic pulmonary arterial pressure measured by catheterization and echocardiography.
timeFrame: During the intervention, at isotime
measure: capillary wedge pressure measured by catheterization and echocardiography.
timeFrame: During the intervention, at isotime
measure: right atrial pressure measured by catheterization and echocardiography.
timeFrame: During the intervention, at isotime
measure: cardiac output measured by catheterization and echocardiography.
timeFrame: During the intervention, at isotime
Other outcomes:
Locations:
city: Rouen
country: France
facility: ROUEN university hospital
Study officials:
affiliation: ADIR Association
name: Elise ARTAUD-MACARI, MD
role: PRINCIPAL_INVESTIGATOR
References: