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

NCT06079151 | Recruiting

• 1 other identifier: HighFlowHD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiac output

  Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min

  During the intervention, at isotime

Secondary Outcomes (49)

• cardiac output

  During the intervention, at isotime

• cardiac output

  During the intervention, at isotime

• Right atrial pressure

  During the intervention, at isotime

• Right atrial pressure

  During the intervention, at isotime

• Right atrial pressure

  During the intervention, at isotime

Study Arms (2)

Nasal high-flow 30 L/min and then 50 L/min

EXPERIMENTAL

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 50 L/min and then 30 L/min

EXPERIMENTAL

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

Interventions

Nasal high-flow DEVICE

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

Nasal high-flow 30 L/min and then 50 L/min; Nasal high-flow 50 L/min and then 30 L/min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ROUEN university hospital

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elise ARTAUD-MACARI, MD

  ADIR Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise ARTAUD-MACARI, MD

CONTACT

+33 2 32 88 59 92; elise.artaud-macari@chu-rouen.fr

Maryline LEFORT, RT

CONTACT

+33 2 32 88 59 92; mlefort@adir-hautenormandie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 12, 2023
• Study Start: February 13, 2024
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

FR (1)