Clinical trial NCT05045105: Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians
Official title: Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Hypertension
Timing of Invasive Intracranial Pressure Monitoring
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All acute brain Injured patients with urgent indication for invasive intracranial pressure monitoring

Brief summary: 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.

Detailed description: 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:

* T0: suspect of pathology at risk for developing intracranial hypertension
* 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)
* T2: skin incision at skull for BOLT/EVD placement

Place of positioning:

The place (intensive care unit or operating room) where the procedure is carried out must be declared.

Eligibility criteria: Inclusion Criteria:

* All patients with acute cerebral pathology with urgent indication to invasive intracranial pressure monitoring (intraparenchymal and intraventricular)
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patients in whom indication to intraventricular catheter placement is stated for reasons other than the need of ICP monitoring (e.g. CSF drainage)
* Patients in whom indication to invasive intracranial pressure monitoring is not an urgent request
* Patients in whom a significative coagulation disorder is a contraindication for procedure

Primary outcomes:
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.
Secondary outcomes:
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)
measure: Length of ICU stay
timeFrame: ICU admission to discharge, up to 30 days
measure: length of hospital stay
timeFrame: hospital admission to discharge, up to 30 days
measure: duration of mechanical ventilation
timeFrame: from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days.
measure: Glasgow Outcome Score at 3 months
timeFrame: 3 months after the acute event
Other outcomes:
Locations:
city: Cesena
country: Italy
facility: Ospedale "M. Bufalini", Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)
state: Forlì-Cesena
city: Legnano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Ovest Milanese (Neurosurgery Unit)
state: Milano
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)
city: Brescia
country: Italy
facility: Spedali Civili di Brescia, Neurosurgery Unit (U.O. Neurochirugia)
city: Brescia
country: Italy
facility: Spedali Civili, Neuro Critical Care Unit (U.O. Anestesia e Rianimazione 2)
city: Caserta
country: Italy
facility: Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta (Neurosurgery Unit)
city: Como
country: Italy
facility: Ospedale Sant'Anna di Como, Intensive Care Unit (U.O. Anestesia e Rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino (Neurosurgery Unit)
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti (Neurosurgery Unit)
city: Lecco
country: Italy
facility: Ospedale A. Manzoni (Intensive Care Unit and Neurosurgery Unit)
city: Modena
country: Italy
facility: Ospedale Civile di Baggiovara (Neurosurgery Unit)
city: Napoli
country: Italy
facility: Ospedale Santa Maria di Loreto Nuovo, Intensive Care Unit (U.O.C. di Terapia Intensiva e Rianimazione), Neurosurgery Unit (U.O.C. Neurochirurgia)
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova (Neurosurgery Unit)
city: Pavia
country: Italy
facility: Policlinico San Matteo, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli (Neurosurgery unit)
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)
city: Udine
country: Italy
facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona (Neurosurgery Unit)
Study officials:
affiliation: Università degli Studi di Brescia
name: Frank Rasulo
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.
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.