Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT02668458
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2016-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe desaturation as defined by a pulse oxymetry below 80%', 'timeFrame': 'through five minutes after preoxygenation period', 'description': 'drop below 80% of pulse oxymetry measurement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure', 'Intratracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '34292408', 'type': 'DERIVED', 'citation': 'Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.'}, {'pmid': '30898520', 'type': 'DERIVED', 'citation': 'Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.'}, {'pmid': '29275345', 'type': 'DERIVED', 'citation': 'Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:\n\n1. NIV (Non Invasive Ventilation)\n2. HFNC (High-flow nasal canula oxygen therapy)', 'detailedDescription': 'Design:\n\nClinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.\n\nSelection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.\n\nRandomized study, inclusion in two groups: NIV or HFNC.\n\nExperimental group:\n\nNHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.\n\nControl group:\n\nNIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.\n\nDuration of participation of each patient: 28 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion Criteria:\n\n* acute hypoxemic respiratory failure requiring endotracheal intubation\n\nMain exclusion Criteria:\n\n* coma\n* NIV contraindication'}, 'identificationModule': {'nctId': 'NCT02668458', 'acronym': 'FLORALI2', 'briefTitle': 'Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)', 'orgStudyIdInfo': {'id': 'FLORALI 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIV', 'description': 'NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.', 'interventionNames': ['Procedure: Noninvasive ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HFNC', 'description': 'High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2', 'interventionNames': ['Procedure: High Flow nasal canula oxygen therapy']}], 'interventions': [{'name': 'High Flow nasal canula oxygen therapy', 'type': 'PROCEDURE', 'description': 'Pre-oxygenation with high-flow nasal canula oxygen therapy', 'armGroupLabels': ['HFNC']}, {'name': 'Noninvasive ventilation', 'type': 'PROCEDURE', 'description': 'Pre-oxygenation with non-invasive ventilation', 'armGroupLabels': ['NIV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU La cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Colombes', 'country': 'France', 'facility': 'CHU louis MOURIER', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Chu Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'La Roche/Yon', 'country': 'France', 'facility': 'CH Vendée'}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'CH La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Limoges University Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CH St Joseph St Luc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Chu E. Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'LYON Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montauban', 'country': 'France', 'facility': 'CH', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': "Hopital de l'Archet", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Orléans', 'country': 'France', 'facility': 'CHU La Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'country': 'France', 'facility': 'Chu Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHU La Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Chu Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pointe à Pitre', 'country': 'France', 'facility': 'CHU Guadeloupe', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'University Hospital of Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Hôpital C. NICOLLE', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital FOCH', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Tours', 'country': 'France', 'facility': 'Chu Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}