An observational study in Intracranial Hypertension and Timing of Invasive Intracranial Pressure Monitoring, sponsored by Università degli Studi di Brescia. Status unknown at 18 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Università degli Studi di Brescia · Observational
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.
185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.
This study's planned enrollment of 64 is close to the median of 60 across 80 observational studies indexed under Intracranial Hypertension.
Browse Intracranial Hypertension studies →Università degli Studi di Brescia is the lead sponsor of 46 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All acute brain Injured patients with urgent indication for invasive intracranial pressure monitoring
Exclusion Criteria:
Intensive Care physicians who will apply the method of invasive insertion of the intracerebral catheter for ICP monitoring
Other: Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication
Neurosurgeons who will apply the method of invasive insertion of the intracerebral catheter for ICP monitoring
Other: Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication
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.
Also known as: Complications related to the maneuver between the two cohorts
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.
Time frame: 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.
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
Time frame: procedure to hospital discharge (in case of malfunction of the catheter, time is up to 12 hours after placement)
Length of ICU stay
Length of ICU stay
Time frame: ICU admission to discharge, up to 30 days
length of hospital stay
length of hospital stay
Time frame: hospital admission to discharge, up to 30 days
duration of mechanical ventilation
duration of mechanical ventilation
Time frame: from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days.
Glasgow Outcome Score at 3 months
Glasgow Outcome Score
Time frame: 3 months after the acute event
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
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Università degli Studi di Brescia