ClinicalTrials.gg
Status unknownNCT06079151HighFlowHDUpdated Apr 19, 2024

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

An interventional study of Nasal high-flow in Pulmonary Hypertension, sponsored by ADIR Association. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by ADIR Association · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • High-flow nasal cannula therapy
  • Hemodynamic monitoring
  • Echocardiography
  • right heart catheterization
03

In context

Hypertension, Pulmonary

1,119 studies on the registry are indexed under Hypertension, Pulmonary; 236 are open to participants now.

This study's planned enrollment of 20 is below the median of 35 across 659 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

ADIR Association is the lead sponsor of 27 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceNasal high-flow

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

06

What researchers measure

Primary outcomes

  1. Cardiac output

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

    Time frame: During the intervention, at isotime

Secondary outcomes

  1. cardiac output

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  2. cardiac output

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  3. Right atrial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  4. Right atrial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  5. Right atrial pressure

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

    Time frame: During the intervention, at isotime

  6. systolic pulmonary arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  7. systolic pulmonary arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  8. systolic pulmonary arterial pressure

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

    Time frame: During the intervention, at isotime

  9. diastolic pulmonary arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  10. diastolic pulmonary arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  11. diastolic pulmonary arterial pressure

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

    Time frame: During the intervention, at isotime

  12. mean pulmonary arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  13. mean pulmonary arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  14. mean pulmonary arterial pressure

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

    Time frame: During the intervention, at isotime

  15. capillary wedge pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  16. capillary wedge pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  17. capillary wedge pressure

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

    Time frame: During the intervention, at isotime

  18. pulmonary vascular resistance

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  19. pulmonary vascular resistance

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  20. pulmonary vascular resistance

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

    Time frame: During the intervention, at isotime

  21. central venous oxygen saturation

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  22. central venous oxygen saturation

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  23. central venous oxygen saturation

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

    Time frame: During the intervention, at isotime

  24. heart rate

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  25. heart rate

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  26. heart rate

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

    Time frame: During the intervention, at isotime

  27. systolic arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  28. systolic arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  29. systolic arterial pressure

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

    Time frame: During the intervention, at isotime

  30. diastolic arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  31. diastolic arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  32. diastolic arterial pressure

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

    Time frame: During the intervention, at isotime

  33. mean arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  34. mean arterial pressure

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  35. mean arterial pressure

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

    Time frame: During the intervention, at isotime

  36. systolic ejection volume

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  37. systolic ejection volume

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  38. systolic ejection volume

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

    Time frame: During the intervention, at isotime

  39. respiratory rate

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  40. respiratory rate

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  41. respiratory rate

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

    Time frame: During the intervention, at isotime

  42. pulse oxygen saturation

    Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  43. pulse oxygen saturation

    Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air

    Time frame: During the intervention, at isotime

  44. pulse oxygen saturation

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

    Time frame: During the intervention, at isotime

  45. 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

    Time frame: During the intervention, at isotime

  46. systolic pulmonary arterial pressure measured by catheterization and echocardiography.

    Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.

    Time frame: During the intervention, at isotime

  47. capillary wedge pressure measured by catheterization and echocardiography.

    Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.

    Time frame: During the intervention, at isotime

  48. right atrial pressure measured by catheterization and echocardiography.

    Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.

    Time frame: During the intervention, at isotime

  49. cardiac output measured by catheterization and echocardiography.

    Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.

    Time frame: During the intervention, at isotime

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06079151
Lead sponsor
ADIR Association
Responsible party
Sponsor
First posted
Oct 12, 2023
Start date
Feb 13, 2024
Primary completion
Feb 12, 2026 (estimated)
Completion
Feb 12, 2026 (estimated)
Last update
Apr 19, 2024

Study contacts

Elise ARTAUD-MACARI, MD
Contact
elise.artaud-macari@chu-rouen.fr
+33 2 32 88 59 92
Maryline LEFORT, RT
Contact
mlefort@adir-hautenormandie.com
+33 2 32 88 59 92
Elise ARTAUD-MACARI, MD
principal investigator · ADIR Association

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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