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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.
Prolonged Intracranial Hypertension has been related to poor outcome and its occurrence has therefore to be assessed as soon as possible.
Invasive 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.
Management 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.
The 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.
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.
Indication 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.
This study will be carried out in Intensive Care Unit and in Neurosurgery department.
Sample size assessment:
Sample 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%.
This 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.
Statistical analysis plan:
Delta time in the placement of invasive ICP monitoring is assumed as T2-T1, declared in minutes.
Typology 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.
The 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.
Timings are defined as:
Place of positioning:
The place (intensive care unit or operating room) where the procedure is carried out must be declared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU physicians | Intensive Care physicians who will apply the method of invasive insertion of the intracerebral catheter for ICP monitoring |
| |
| Neurosurgeons | Neurosurgeons who will apply the method of invasive insertion of the intracerebral catheter for ICP monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare timing of invasive intracranial pressure monitoring performed by intensive care physicians and neurosurgeons | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative evaluation of post-procedural complications between intensivists and neurosurgeons | Comparative evaluation of post-procedural complications (meningitis, catheter-placement related bleedings, wrong placement) between intensivists and neurosurgeons | procedure to hospital discharge (in case of malfunction of the catheter, time is up to 12 hours after placement) |
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Inclusion Criteria:
Exclusion Criteria:
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All acute brain Injured patients with urgent indication for invasive intracranial pressure monitoring
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank A Rasulo | Contact | +39 3393366290 | frank.rasulo@gmail.com | |
| Giovanni Chiarini | Contact | +39 3473926790 | giovanni.chiarini88@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Frank Rasulo | Università degli Studi di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale "M. Bufalini", Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia) | Not yet recruiting | Cesena | Forlì-Cesena | 47521 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16498188 | Background | 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. | |
| 18826355 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2021 |
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|
|
| Length of ICU stay | Length of ICU stay | ICU admission to discharge, up to 30 days |
| length of hospital stay | length of hospital stay | hospital admission to discharge, up to 30 days |
| duration of mechanical ventilation | duration of mechanical ventilation | from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days. |
| Glasgow Outcome Score at 3 months | Glasgow Outcome Score | 3 months after the acute event |
| Azienda Socio Sanitaria Territoriale Ovest Milanese (Neurosurgery Unit) | Not yet recruiting | Legnano | Milano | 20025 | Italy |
|
| Ospedale Papa Giovanni XXIII, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia) | Not yet recruiting | Bergamo | 24127 | Italy |
|
| Spedali Civili di Brescia, Neurosurgery Unit (U.O. Neurochirugia) | Recruiting | Brescia | 25123 | Italy |
|
| Spedali Civili, Neuro Critical Care Unit (U.O. Anestesia e Rianimazione 2) | Recruiting | Brescia | 25123 | Italy |
|
| Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta (Neurosurgery Unit) | Not yet recruiting | Caserta | 81100 | Italy |
|
| Ospedale Sant'Anna di Como, Intensive Care Unit (U.O. Anestesia e Rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia) | Not yet recruiting | Como | 22100 | Italy |
|
| Ospedale Policlinico San Martino (Neurosurgery Unit) | Not yet recruiting | Genova | 16132 | Italy |
|
| Ospedale Santa Maria Goretti (Neurosurgery Unit) | Not yet recruiting | Latina | 04100 | Italy |
|
| Ospedale A. Manzoni (Intensive Care Unit and Neurosurgery Unit) | Not yet recruiting | Lecco | 23900 | Italy |
|
| Ospedale Civile di Baggiovara (Neurosurgery Unit) | Not yet recruiting | Modena | 41126 | Italy |
|
| Ospedale Santa Maria di Loreto Nuovo, Intensive Care Unit (U.O.C. di Terapia Intensiva e Rianimazione), Neurosurgery Unit (U.O.C. Neurochirurgia) | Not yet recruiting | Naples | 80142 | Italy |
|
| Azienda Ospedale Università Padova (Neurosurgery Unit) | Not yet recruiting | Padova | 35128 | Italy |
|
| Policlinico San Matteo, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia) | Not yet recruiting | Pavia | 27100 | Italy |
|
| Policlinico Universitario Agostino Gemelli (Neurosurgery unit) | Not yet recruiting | Roma | 00168 | Italy |
|
| Azienda Ospedaliera Città della Salute e della Scienza, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia) | Not yet recruiting | Torino | 10126 | Italy |
|
| Presidio Ospedaliero Universitario Santa Maria della Misericordia, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit | Not yet recruiting | Udine | 33100 | Italy |
|
| Azienda Ospedaliera Universitaria Integrata Verona (Neurosurgery Unit) | Not yet recruiting | Verona | 37126 | Italy |
|
| 23055087 | Background | 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. |
| 14501890 | Background | 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. |
| 18449808 | Background | 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. |
| 22929484 | Background | 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. |
| 23473439 | Background | 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. |
| Jul 22, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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