Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-06-25 @ 1:08 AM
Study NCT ID:
NCT05045105
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-30', 'size': 405446, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-22T21:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-05-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2021-07-22', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare timing of invasive intracranial pressure monitoring performed by intensive care physicians and neurosurgeons', 'timeFrame': 'The time frame, will be from when the suspicion of a potential increase in ICP is given to when the actual skin incision for the insertion of the invasive catheter placement is performed. From indication up to 5 hours.', 'description': 'The time frame, which also represents the main outcome of this study, is defined as the time-difference between the moment when indication of invasive ICP monitoring is given and the moment when the skin incision is performed for ICP monitoring placement.'}], 'secondaryOutcomes': [{'measure': 'Comparative evaluation of post-procedural complications between intensivists and neurosurgeons', 'timeFrame': 'procedure to hospital discharge (in case of malfunction of the catheter, time is up to 12 hours after placement)', 'description': 'Comparative evaluation of post-procedural complications (meningitis, catheter-placement related bleedings, wrong placement) between intensivists and neurosurgeons'}, {'measure': 'Length of ICU stay', 'timeFrame': 'ICU admission to discharge, up to 30 days', 'description': 'Length of ICU stay'}, {'measure': 'length of hospital stay', 'timeFrame': 'hospital admission to discharge, up to 30 days', 'description': 'length of hospital stay'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days.', 'description': 'duration of mechanical ventilation'}, {'measure': 'Glasgow Outcome Score at 3 months', 'timeFrame': '3 months after the acute event', 'description': 'Glasgow Outcome Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Hypertension', 'Timing of Invasive Intracranial Pressure Monitoring']}, 'referencesModule': {'references': [{'pmid': '16498188', 'type': 'BACKGROUND', 'citation': 'Balestreri M, Czosnyka M, Hutchinson P, Steiner LA, Hiler M, Smielewski P, Pickard JD. Impact of intracranial pressure and cerebral perfusion pressure on severe disability and mortality after head injury. Neurocrit Care. 2006;4(1):8-13. doi: 10.1385/NCC:4:1:008.'}, {'pmid': '18826355', 'type': 'BACKGROUND', 'citation': 'Vik A, Nag T, Fredriksli OA, Skandsen T, Moen KG, Schirmer-Mikalsen K, Manley GT. Relationship of "dose" of intracranial hypertension to outcome in severe traumatic brain injury. J Neurosurg. 2008 Oct;109(4):678-84. doi: 10.3171/JNS/2008/109/10/0678.'}, {'pmid': '23055087', 'type': 'BACKGROUND', 'citation': 'Sheth KN, Stein DM, Aarabi B, Hu P, Kufera JA, Scalea TM, Hanley DF. Intracranial pressure dose and outcome in traumatic brain injury. Neurocrit Care. 2013 Feb;18(1):26-32. doi: 10.1007/s12028-012-9780-3.'}, {'pmid': '14501890', 'type': 'BACKGROUND', 'citation': 'Ko K, Conforti A. Training protocol for intracranial pressure monitor placement by nonneurosurgeons: 5-year experience. J Trauma. 2003 Sep;55(3):480-3; discussion 483-4. doi: 10.1097/01.TA.0000074111.04885.28.'}, {'pmid': '18449808', 'type': 'BACKGROUND', 'citation': 'Ehtisham A, Taylor S, Bayless L, Klein MW, Janzen JM. Placement of external ventricular drains and intracranial pressure monitors by neurointensivists. Neurocrit Care. 2009;10(2):241-7. doi: 10.1007/s12028-008-9097-4.'}, {'pmid': '22929484', 'type': 'BACKGROUND', 'citation': 'Barber MA, Helmer SD, Morgan JT, Haan JM. Placement of intracranial pressure monitors by non-neurosurgeons: excellent outcomes can be achieved. J Trauma Acute Care Surg. 2012 Sep;73(3):558-63; discussion 563-5. doi: 10.1097/TA.0b013e318265cb75.'}, {'pmid': '23473439', 'type': 'BACKGROUND', 'citation': 'Sadaka F, Kasal J, Lakshmanan R, Palagiri A. Placement of intracranial pressure monitors by neurointensivists: case series and a systematic review. Brain Inj. 2013;27(5):600-4. doi: 10.3109/02699052.2013.772238. Epub 2013 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Invasive intracranial pressure monitoring takes on essential importance in patients with traumatic brain injury and in all cerebral pathologies in which intracranial hypertension is the main cause of death.\n\nProlonged Intracranial Hypertension has been related to poor outcome and its occurrence has therefore to be assessed as soon as possible.\n\nInvasive intracranial pressure monitoring performed by placing an intracerebral catheter is currently the gold standard technique for continuous ICP invasive monitoring. This maneuver has usually been performed by neurosurgeons, but recently this procedure has more often been carried out by intensivists, at the bedside.\n\nManagement of intracranial pressure handling and treatment is currently achieved by joint decisions between neurosurgeons and intensive care physicians, but differences in logistic matters and in the executive availability could impact on the dose of intracranial pressure to which patient is exposed.\n\nThe aim of this study is to compare timing of invasive intracranial pressure monitoring placement performed by intensive care physicians and neurosurgeons and to detect possible differences in the incidence of complications between the two groups.', 'detailedDescription': 'This perspective, multicentric and observational study will enroll patients at risk for developing intracranial hypertension, for whom it is thought invasive ICP monitoring is crucial for achieving the most appropriate treatment.\n\nIndication to invasive ICP monitoring and its modalities will be set through a joint decision between neurosurgeons and intensive care physician, which will be led by clinical and instrumental data.\n\nThis study will be carried out in Intensive Care Unit and in Neurosurgery department.\n\nSample size assessment:\n\nSample size assessment has been performed by Monte Carlo simulation (B=500). Assuming a timing decrease (T2-T1) of 20 minutes in the procedure carried out by an intensivist compared to a neurosurgeon, with a mean time of 100 minutes, a standard deviation between center and intra-center of 10 minutes, 16 centers, each one with the same number of patients and a balance 1:1 between the two groups (intensivist:neurosurgeon), a total number of 64 patients (32 treated by intensivists and 32 by neurosurgeons), it allows us to evaluate the interest effect with a power of at least 95%, and a significance level of 5%.\n\nThis elevated power has been decided according to the simplicity of the assumed design (same number of entities and conditions for center) and not evaluable in his real configuration.\n\nStatistical analysis plan:\n\nDelta time in the placement of invasive ICP monitoring is assumed as T2-T1, declared in minutes.\n\nTypology operator (neurosurgeon vs intensivist) impact on delta time will be evaluated through a multilevel model elaborated with a linear mixed model. The model will assume the center in which the maneuver is carried out as clustering factor. The place where the maneuver is carried out (intensive care unit vs operating room) and the confidence in performing the procedure (routine vs sporadic, defined as less than 5 times a year) will be assumed as covariates.\n\nThe incidence of complications, valued as a binary variable, will be evaluated through logistic model GLMM (generalized linear mixed model) with the organization exposed in the dedicated data element.\n\nTimings are defined as:\n\n* T0: suspect of pathology at risk for developing intracranial hypertension\n* T1: neurointensive and neurosurgical indication to invasive ICP monitoring (it can be the time when brain CT is performed or, in the absence of a brain CT, the time at which indication to invasive ICP monitoring is stated)\n* T2: skin incision at skull for BOLT/EVD placement\n\nPlace of positioning:\n\nThe place (intensive care unit or operating room) where the procedure is carried out must be declared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All acute brain Injured patients with urgent indication for invasive intracranial pressure monitoring', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with acute cerebral pathology with urgent indication to invasive intracranial pressure monitoring (intraparenchymal and intraventricular)\n* Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Patients in whom indication to intraventricular catheter placement is stated for reasons other than the need of ICP monitoring (e.g. CSF drainage)\n* Patients in whom indication to invasive intracranial pressure monitoring is not an urgent request\n* Patients in whom a significative coagulation disorder is a contraindication for procedure'}, 'identificationModule': {'nctId': 'NCT05045105', 'acronym': 'TIMING-ICP', 'briefTitle': 'Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians', 'orgStudyIdInfo': {'id': 'NP4628'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU physicians', 'description': 'Intensive Care physicians who will apply the method of invasive insertion of the intracerebral catheter for ICP monitoring', 'interventionNames': ['Other: Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication']}, {'label': 'Neurosurgeons', 'description': 'Neurosurgeons who will apply the method of invasive insertion of the intracerebral catheter for ICP monitoring', 'interventionNames': ['Other: Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication']}], 'interventions': [{'name': 'Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication', 'type': 'OTHER', 'otherNames': ['Complications related to the maneuver between the two cohorts'], 'description': 'Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication and complications related to the maneuver between the two cohorts will be evaluated and compared.', 'armGroupLabels': ['ICU physicians', 'Neurosurgeons']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47521', 'city': 'Cesena', 'state': 'Forlì-Cesena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Russo', 'role': 'CONTACT', 'email': 'lelegaiola@gmail.com'}], 'facility': 'Ospedale "M. Bufalini", Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}, {'zip': '20025', 'city': 'Legnano', 'state': 'Milano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Stefini', 'role': 'CONTACT', 'email': 'roberto.stefini@gmail.com'}, {'name': 'Paola Fassini', 'role': 'CONTACT', 'email': 'paola.fassini@asst-ovestmi.it'}], 'facility': 'Azienda Socio Sanitaria Territoriale Ovest Milanese (Neurosurgery Unit)', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'zip': '24127', 'city': 'Bergamo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Gritti', 'role': 'CONTACT', 'email': 'grittip@libero.it'}], 'facility': 'Ospedale Papa Giovanni XXIII, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '25123', 'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Biroli', 'role': 'CONTACT', 'email': 'biroli.francesco@gmail.com'}, {'name': 'Lucio De Maria', 'role': 'CONTACT', 'email': 'luciodemaria@gmail.com'}], 'facility': 'Spedali Civili di Brescia, Neurosurgery Unit (U.O. Neurochirugia)', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '25123', 'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Frank Rasulo', 'role': 'CONTACT', 'email': 'frank.rasulo@gmail.com'}, {'name': 'Giovanni Chiarini', 'role': 'CONTACT', 'email': 'giovanni.chiarini88@gmail.com', 'phone': '+39 3473926790'}], 'facility': 'Spedali Civili, Neuro Critical Care Unit (U.O. Anestesia e Rianimazione 2)', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '81100', 'city': 'Caserta', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nadia Zarrillo', 'role': 'CONTACT', 'email': 'nadia.zarrillo@libero.it'}], 'facility': "Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta (Neurosurgery Unit)", 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'zip': '22100', 'city': 'Como', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Zerbi', 'role': 'CONTACT', 'email': 'smzerbi@gmail.com'}], 'facility': "Ospedale Sant'Anna di Como, Intensive Care Unit (U.O. Anestesia e Rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '16132', 'city': 'Genova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Robba', 'role': 'CONTACT', 'email': 'kiarobba@gmail.com'}], 'facility': 'Ospedale Policlinico San Martino (Neurosurgery Unit)', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '04100', 'city': 'Latina', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Pompucci', 'role': 'CONTACT', 'email': 'angelo.pompucci@gmail.com'}], 'facility': 'Ospedale Santa Maria Goretti (Neurosurgery Unit)', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '23900', 'city': 'Lecco', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Forastieri', 'role': 'CONTACT', 'email': 'a.forastieri@asst-lecco.it'}], 'facility': 'Ospedale A. Manzoni (Intensive Care Unit and Neurosurgery Unit)', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '41126', 'city': 'Modena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Corrado Iaccarino', 'role': 'CONTACT', 'email': 'iaccarino.corrado@gmail.com'}], 'facility': 'Ospedale Civile di Baggiovara (Neurosurgery Unit)', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80142', 'city': 'Napoli', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Toto', 'role': 'CONTACT', 'email': 'rtoto@libero.it'}], 'facility': 'Ospedale Santa Maria di Loreto Nuovo, Intensive Care Unit (U.O.C. di Terapia Intensiva e Rianimazione), Neurosurgery Unit (U.O.C. Neurochirurgia)', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marina Munari', 'role': 'CONTACT', 'email': 'marina.munari@aopd.veneto.it'}], 'facility': 'Azienda Ospedale Università Padova (Neurosurgery Unit)', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '27100', 'city': 'Pavia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Danila Radolovich', 'role': 'CONTACT', 'email': 'iperdany@hotmail.com'}], 'facility': 'Policlinico San Matteo, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '00168', 'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anselmo Caricato', 'role': 'CONTACT', 'email': 'anselmo.Caricato@unicatt.it'}], 'facility': 'Policlinico Universitario Agostino Gemelli (Neurosurgery unit)', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maurizio Berardino', 'role': 'CONTACT', 'email': 'maurizio_berardino@fastwebnet.it'}], 'facility': 'Azienda Ospedaliera Città della Salute e della Scienza, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '33100', 'city': 'Udine', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristian Deana', 'role': 'CONTACT', 'email': 'deana.cristian@gmail.com'}], 'facility': 'Presidio Ospedaliero Universitario Santa Maria della Misericordia, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '37126', 'city': 'Verona', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Gelormini', 'role': 'CONTACT', 'email': 'dgelor@gmail.com'}, {'name': 'Marilena Liviero', 'role': 'CONTACT', 'email': 'marilena.casartelliliviero@aovr.veneto.it'}], 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona (Neurosurgery Unit)', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Frank A Rasulo', 'role': 'CONTACT', 'email': 'frank.rasulo@gmail.com', 'phone': '+39 3393366290'}, {'name': 'Giovanni Chiarini', 'role': 'CONTACT', 'email': 'giovanni.chiarini88@gmail.com', 'phone': '+39 3473926790'}], 'overallOfficials': [{'name': 'Frank Rasulo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Anesthesiology and Intensive Care', 'investigatorFullName': 'Dr. Frank Rasulo', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}