Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06194058
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a major haemodynamic disorder', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': 'MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or occurrence of a sustained arrhythmia (\\> 1 min) not present at induction and/or cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Clinical pre-anesthesic assessment of the risk of a full stomach', 'timeFrame': 'From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure', 'description': '\\- percentage of clinical and/or imaging endpoints in favor of a full stomach'}, {'measure': 'Pre-anesthetic assessment of the risk of a full stomach', 'timeFrame': 'From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure', 'description': '\\- percentage of gastric ultrasound use'}, {'measure': 'Assessment of the risk of a full stomach', 'timeFrame': 'From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure', 'description': '\\- percentage of presence and use of the Nasogastric Tube'}, {'measure': 'Team involved in the rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- average number of individuals in the room participating in the performance of SRI'}, {'measure': 'Preparation for rapide sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- Percentage of patients in supine position'}, {'measure': 'Use of morphine for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of use of morphine derivative prior to airway securisation'}, {'measure': 'Induction therapeutics for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of use of each of the following hypnotics: propofol, ketamine, thiopental, etomidate, midazolam, sevoflurane'}, {'measure': 'Use of curare for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of use of a curare'}, {'measure': 'Use of vasopressive amine for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage and median dosage of vasopressive amine use for the prevention of low blood pressure'}, {'measure': 'Use of filling solution for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage and median volume of use of a preventive vascular filling solution'}, {'measure': 'Airway management for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- type of preoxygenation'}, {'measure': 'Operator qualification for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentages of first operator with a medical degree, of trained nurses, and of medical resident performing the rapid sequence induction technique'}, {'measure': 'Laryngoscopy for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of use of a video laryngoscope as a 1st intention'}, {'measure': 'Medical device used for rapid sequence induction technique', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of mandrel use at the first laryngoscopy'}, {'measure': 'MBP complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of episode of MBP ≤ at 50 mmHg (or ≤ 40% of the baseline)'}, {'measure': 'Tension complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of episode of MBP ≥ 110 mmHg'}, {'measure': 'Rythmal complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- sustained arrhythmia (\\> 1 minute) not present at induction'}, {'measure': 'Cardiac complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- cardiac arrest'}, {'measure': 'Intubation complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of intubations that required more than one laryngoscopy'}, {'measure': 'Low tension-related complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage and median dosage of use of a vasopressive amine required for the treatment of low blood pressure (defined as a SBP \\< 80 mmHg)'}, {'measure': 'High tension-related complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of use of an antihypertensive drug or sedation-analgesia bolus for the treatment of high blood pressure (defined as SBP \\> 160 mmHg)'}, {'measure': 'Respiratory complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of respiratory complication defined by Spo2 \\< 90% or the need for manual reventilation'}, {'measure': 'Anaphylactic complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of Grade I, II, III or IV anaphylactic reaction'}, {'measure': 'Inhalation complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of gastric fluid inhalation defined by the presence of non-salivary fluid or supraglottic solids during laryngoscopy'}, {'measure': 'Immediate complications of ISR (< 10 minutes)', 'timeFrame': 'Within the first 10 minutes after induction of anesthesia', 'description': '\\- percentage of intraoperative deaths'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthetic induction', 'adult patients', 'hemodynamic disorders', 'arrythmia', 'cardiac arrest', 'pre-oxygenation', 'mean blood pressure'], 'conditions': ['Rapid Sequence Intubation']}, 'descriptionModule': {'briefSummary': 'There is a great heterogeneity in the practice of rapid sequence induction in the operating room in the world. There are no recent data assessing the rate of implementation of the latest French formalized expert recommendations in clinical practice. In addition, the modalities for the management of haemodynamic disorders, particularly hypotensive disorders, during rapid sequence induction are not described in these recommendations, although these are frequent events with a non-zero morbidity mortality potential.\n\nThe goal of this prospective, observational, multicenter, anesthetic study is to describe the clinical practice of French anesthesiologists regarding the prevention of severe hemodynamic disorders during rapid sequence anesthetic induction in adult patients.\n\nThe primary outcome measure is the occurrence of a major haemodynamic disorder defined by a MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or the occurrence of sustained arrhythmia not present at induction and/or cardiac arrest within the first 10 minutes after induction of anesthesia.\n\nThe clinical practices of pre-oxygenation, induction and intubation of French anesthesiologists and compliance with the formalized expert recommendations of 2017 and 2018 will also be studied secondarily. The elements for the prevention of gastric fluid inhalation, the organization and equipment used, the anesthetic and non-anesthetic drugs used, the clinical and paraclinical neurological and cardio-respiratory parameters and the nature of the complications following anaesthetic induction will be collected up to the 10th post-induction minute.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients for whom rapid sequence anesthetic induction has been retained in the operating room and for whom no opposition has been obtained during the anesthesia consultation will be included consecutively.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years' old\n* Procedure requiring general anesthesia with oro or nasotracheal intubation\n* Anesthetic management with indication of rapid sequence induction\n* No objection after oral and written information to the patient\n\nExclusion Criteria:\n\n* Age \\< 18 years' old\n* Impossible intubation planned\n* Preoperative respiratory distress (SpO2 \\< 90% in ambient air)\n* Preoperative shock (MBP≤ 65 mmHg or vasopressive amines)\n* Preoperative coma defined by a Glasgow score ≤ 12/15\n* Patient in cardiopulmonary arrest\n* Patients under guardianship or curatorship"}, 'identificationModule': {'nctId': 'NCT06194058', 'acronym': 'CoC', 'briefTitle': 'Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study. The Crush or Crash Study.', 'orgStudyIdInfo': {'id': 'AR_2023_001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rapid sequence anesthetic induction', 'type': 'OTHER', 'description': "Rapid sequence induction and intubation (or crash induction) is a process for inducing general anesthesia when the patient is at a high risk of pulmonary aspiration. It aims at minimizing the time between giving the induction drugs and securing the tube, during which period the patient's airway is essentially unprotected."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Huette', 'role': 'CONTACT'}], 'facility': 'Clinique Victor Pauchet', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Arcachon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jeremy Allary', 'role': 'CONTACT', 'email': 'Jeremy.Allary@ch-arcachon.fr'}], 'facility': 'Hospital', 'geoPoint': {'lat': 44.66126, 'lon': -1.17255}}, {'city': 'Armentières', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lucile Debaecker', 'role': 'CONTACT', 'email': 'l.debaecker@ch-armentieres.fr'}], 'facility': 'Hospital', 'geoPoint': {'lat': 50.68568, 'lon': 2.88214}}, {'city': 'Arras', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthias Garrot', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé Arras les Bonnettes', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anais Caillard', 'role': 'CONTACT'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valentin Lefrancois', 'role': 'CONTACT', 'email': 'lefrancois-v@chu-caen.fr'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Castres', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde Vernet', 'role': 'CONTACT', 'email': 'mathilde.vernet@chic-cm.fr'}], 'facility': 'Centre Hospitalier Intercommunal', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Godet', 'role': 'CONTACT', 'email': 'tgodet@chu-clermontferrand.fr'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu Oudot', 'role': 'CONTACT'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victor Lestrade', 'role': 'CONTACT'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lorient', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Seamus Thierry', 'role': 'CONTACT', 'email': 's.thierry@ghbs.bzh'}], 'facility': 'Hospital', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Grégoire Wallon', 'role': 'CONTACT'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Desebbe', 'role': 'CONTACT'}], 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu Fontaine', 'role': 'CONTACT', 'email': 'mfontaine@saintjosephsaintluc.fr'}], 'facility': 'Saint Joseph Saint Luc Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emma Aka', 'role': 'CONTACT', 'email': 'emma.aka@chu-lyon.fr'}], 'facility': 'University Hopital - Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Bouchet', 'role': 'CONTACT', 'email': 'marc.bouchet@chu-lyon.fr'}], 'facility': 'University Hospital - Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Mont-de-Marsan', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Andersen Ramorasata', 'role': 'CONTACT', 'email': 'andersen.ramorasata@ch-mdm.fr'}], 'facility': 'Hospital', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'city': 'Montargis', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ahiab Alnumier', 'role': 'CONTACT', 'email': 'aalnumier@ch-montargis.fr'}], 'facility': 'Hospital', 'geoPoint': {'lat': 47.99696, 'lon': 2.73261}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hugo Ingles', 'role': 'CONTACT'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victor Gridel', 'role': 'CONTACT', 'email': 'gridel.v@chu-nice.fr'}], 'facility': 'University Hospital - Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélie Gouel', 'role': 'CONTACT', 'email': 'aurelie.gouel@aphp.fr'}], 'facility': 'Bichat Hospital - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Dagois', 'role': 'CONTACT', 'email': 'sophie.dagois@aphp.fr'}], 'facility': 'Hopital Lariboisiere - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dimitri Margetis', 'role': 'CONTACT', 'email': 'dimitri.margetis@aphp.fr'}], 'facility': 'Hopital Pitié Salpetriere - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anouare Friaa', 'role': 'CONTACT', 'email': 'anouare.friaa@aphp.fr'}], 'facility': 'Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gauthier Hamon', 'role': 'CONTACT'}], 'facility': 'Hôpital Tenon - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin Saint Genis', 'role': 'CONTACT', 'email': 'Quentin.SAINT-GENIS@chu-poitiers.fr'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie Chevalier', 'role': 'CONTACT', 'email': 'stephanie.chevalier@hospigrandouest.fr'}], 'facility': 'Clinique de la Sagesse', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rodez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Delmas', 'role': 'CONTACT', 'email': 'J.DELMAS@ch-rodez.fr'}], 'facility': 'Hospital', 'geoPoint': {'lat': 44.35258, 'lon': 2.57338}}, {'city': 'Saint-Brieuc', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lauren Daviet', 'role': 'CONTACT', 'email': 'lauren.daviet@armorsante.bzh'}], 'facility': 'Yves Le Foll Hospital', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Denis', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Thiltges', 'role': 'CONTACT', 'email': 'laurent.thiltges@chu-reunion.fr'}], 'facility': 'University Hospital La Réunion - Site Nord', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'city': 'Saint-Paul', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexis Carpentier', 'role': 'CONTACT', 'email': 'Al.CARPENTIER@chor.re'}], 'facility': 'University Hospital La Réunion - site Ouest', 'geoPoint': {'lat': 49.42962, 'lon': 2.00755}}, {'city': 'Seclin', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Turbelin', 'role': 'CONTACT', 'email': 'alexandre.turbelin@ghsc.fr'}], 'facility': 'Groupe Hospitalier Seclin Carvin', 'geoPoint': {'lat': 50.54873, 'lon': 3.02731}}, {'city': 'Soyaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gianluca Caragliano', 'role': 'CONTACT'}], 'facility': 'Centre Clinical - Angoulême', 'geoPoint': {'lat': 45.64052, 'lon': 0.19752}}, {'city': 'St-Malo', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Allo', 'role': 'CONTACT', 'email': 'G.ALLO@ch-stmalo.fr'}], 'facility': 'Hospital', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nadège Erb', 'role': 'CONTACT'}], 'facility': 'Clinique Rhéna', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Gaudefroy', 'role': 'CONTACT', 'email': 'julie.gaudefroy@chru-strasbourg.fr'}], 'facility': 'University Hospital - Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Thonon-les-Bains', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline Gauthier', 'role': 'CONTACT', 'email': 'C-GAUTHIER@ch-hopitauxduleman.fr'}], 'facility': 'Hôpitaux du Leman', 'geoPoint': {'lat': 46.37049, 'lon': 6.47985}}, {'city': 'Toulon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Prieur', 'role': 'CONTACT', 'email': 'SOPHIE.PRIEUR@ch-toulon.fr'}], 'facility': 'Centre hospitalier intercommunal', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent Pey', 'role': 'CONTACT', 'email': 'pey.vi@chu-toulouse.fr'}], 'facility': 'University Hospital - Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fanny Cointre', 'role': 'CONTACT'}], 'facility': 'Hospital', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'city': 'Villejuif', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jamie Elmawieh', 'role': 'CONTACT', 'email': 'Jamie.ELMAWIEH@gustaveroussy.fr'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villeneuve-Saint-Georges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Virginie Trehel-Tursis', 'role': 'CONTACT'}], 'facility': 'Clinique de Villeneuve Saint Georges', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}], 'centralContacts': [{'name': 'Hugo Ingles, MD', 'role': 'CONTACT', 'email': 'hugo.ingles@chu-nantes.fr', 'phone': '+33.2.40.08.73.80'}, {'name': 'Nicolas Grillot, MD', 'role': 'CONTACT', 'email': 'nicolas.grillot@chu-nantes.fr', 'phone': '+33.2.40.08.73.80'}], 'overallOfficials': [{'name': 'Nicolas Grillot, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Société Française d'Anesthésie et de Réanimation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}