Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-28 @ 10:47 PM
Study NCT ID:
NCT06079151
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-02-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}], 'secondaryOutcomes': [{'measure': 'cardiac output', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'cardiac output', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'Right atrial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'Right atrial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'Right atrial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'systolic pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'systolic pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'systolic pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'diastolic pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'diastolic pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'diastolic pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'mean pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'mean pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'mean pulmonary arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'capillary wedge pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'capillary wedge pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'capillary wedge pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'pulmonary vascular resistance', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'pulmonary vascular resistance', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'pulmonary vascular resistance', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'central venous oxygen saturation', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'central venous oxygen saturation', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'central venous oxygen saturation', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'heart rate', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'heart rate', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'heart rate', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'systolic arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'systolic arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'systolic arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'diastolic arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'diastolic arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'diastolic arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'mean arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'mean arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'mean arterial pressure', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'systolic ejection volume', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'systolic ejection volume', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'systolic ejection volume', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'respiratory rate', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'respiratory rate', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'respiratory rate', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'pulse oxygen saturation', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air'}, {'measure': 'pulse oxygen saturation', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air'}, {'measure': 'pulse oxygen saturation', 'timeFrame': 'During the intervention, at isotime', 'description': 'Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min'}, {'measure': 'Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.', 'timeFrame': 'During the intervention, at isotime', 'description': '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'}, {'measure': 'systolic pulmonary arterial pressure measured by catheterization and echocardiography.', 'timeFrame': 'During the intervention, at isotime', 'description': 'Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.'}, {'measure': 'capillary wedge pressure measured by catheterization and echocardiography.', 'timeFrame': 'During the intervention, at isotime', 'description': 'Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.'}, {'measure': 'right atrial pressure measured by catheterization and echocardiography.', 'timeFrame': 'During the intervention, at isotime', 'description': 'Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.'}, {'measure': 'cardiac output measured by catheterization and echocardiography.', 'timeFrame': 'During the intervention, at isotime', 'description': 'Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High-flow nasal cannula therapy', 'Hemodynamic monitoring', 'Echocardiography', 'right heart catheterization'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.\n\nExclusion Criteria:\n\n* necessity of FiO2 \\>21% during right heart catheterization\n* intracardiac shunt\n* grade 4 tricuspid insufficiency\n* complete arrhythmia due to atrial fibrillation\n* Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception\n* protected adult patient (tutorship or curatorship)\n* patient deprived of liberty by court or administrative decision\n* refusal of patient participation or consent\n* patient for whom the measurement of pulmonary arterial pressures during right heart catheterization is impossible\n* 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.'}, 'identificationModule': {'nctId': 'NCT06079151', 'acronym': 'HighFlowHD', 'briefTitle': 'Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'ADIR Association'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HighFlowHD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal high-flow 30 L/min and then 50 L/min', 'description': 'The patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 min.', 'interventionNames': ['Device: Nasal high-flow']}, {'type': 'EXPERIMENTAL', 'label': 'Nasal high-flow 50 L/min and then 30 L/min', 'description': 'The patient will be placed successively under nasal high-flow 50 L/min during 20 min and then 30 L/min during 20 min.', 'interventionNames': ['Device: Nasal high-flow']}], 'interventions': [{'name': 'Nasal high-flow', 'type': 'DEVICE', 'description': 'Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary', 'armGroupLabels': ['Nasal high-flow 30 L/min and then 50 L/min', 'Nasal high-flow 50 L/min and then 30 L/min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elise Artaud-Macari, MD', 'role': 'CONTACT', 'email': 'eliseartaudmacari@yahoo.fr'}], 'facility': 'ROUEN university hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Elise ARTAUD-MACARI, MD', 'role': 'CONTACT', 'email': 'elise.artaud-macari@chu-rouen.fr', 'phone': '+33 2 32 88 59 92'}, {'name': 'Maryline LEFORT, RT', 'role': 'CONTACT', 'email': 'mlefort@adir-hautenormandie.com', 'phone': '+33 2 32 88 59 92'}], 'overallOfficials': [{'name': 'Elise ARTAUD-MACARI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ADIR Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADIR Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}