Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05045105
Other study ID # NP4628
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 27, 2021
Est. completion date May 3, 2022

Study information

Verified date September 2021
Source Università degli Studi di Brescia
Contact Frank A Rasulo
Phone +39 3393366290
Email frank.rasulo@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date May 3, 2022
Est. primary completion date May 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Ospedale Papa Giovanni XXIII, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia) Bergamo
Italy Spedali Civili di Brescia, Neurosurgery Unit (U.O. Neurochirugia) Brescia
Italy Spedali Civili, Neuro Critical Care Unit (U.O. Anestesia e Rianimazione 2) Brescia
Italy Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta (Neurosurgery Unit) Caserta
Italy Ospedale "M. Bufalini", Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia) Cesena Forlì-Cesena
Italy Ospedale Sant'Anna di Como, Intensive Care Unit (U.O. Anestesia e Rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia) Como
Italy Ospedale Policlinico San Martino (Neurosurgery Unit) Genova
Italy Ospedale Santa Maria Goretti (Neurosurgery Unit) Latina
Italy Ospedale A. Manzoni (Intensive Care Unit and Neurosurgery Unit) Lecco
Italy Azienda Socio Sanitaria Territoriale Ovest Milanese (Neurosurgery Unit) Legnano Milano
Italy Ospedale Civile di Baggiovara (Neurosurgery Unit) Modena
Italy Ospedale Santa Maria di Loreto Nuovo, Intensive Care Unit (U.O.C. di Terapia Intensiva e Rianimazione), Neurosurgery Unit (U.O.C. Neurochirurgia) Napoli
Italy Azienda Ospedale Università Padova (Neurosurgery Unit) Padova
Italy Policlinico San Matteo, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia) Pavia
Italy Policlinico Universitario Agostino Gemelli (Neurosurgery unit) Roma
Italy Azienda Ospedaliera Città della Salute e della Scienza, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia) Torino
Italy Presidio Ospedaliero Universitario Santa Maria della Misericordia, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit Udine
Italy Azienda Ospedaliera Universitaria Integrata Verona (Neurosurgery Unit) Verona

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary 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)
Secondary Length of ICU stay Length of ICU stay ICU admission to discharge, up to 30 days
Secondary length of hospital stay length of hospital stay hospital admission to discharge, up to 30 days
Secondary duration of mechanical ventilation duration of mechanical ventilation from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days.
Secondary Glasgow Outcome Score at 3 months Glasgow Outcome Score 3 months after the acute event
See also
  Status Clinical Trial Phase
Completed NCT06367868 - Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring N/A
Completed NCT04488874 - Sodium Lactate and Brain Relaxation (LSD) Phase 3
Not yet recruiting NCT04211064 - Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter N/A
Completed NCT00571623 - Automated Chest Physiotherapy to Improve Outcomes in Neuro N/A
Recruiting NCT00437814 - Effect of Ketamine (Ketalar) on Intracranial Pressure N/A
Recruiting NCT03212976 - Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure N/A
Withdrawn NCT02558309 - Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure N/A
Terminated NCT00795587 - Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring Phase 4
Completed NCT00447018 - Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure Phase 4
Not yet recruiting NCT05593380 - The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH N/A
Completed NCT03364634 - Intracranial Pressure After Decompressive Craniectomy N/A
Unknown status NCT02773901 - Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement N/A
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Terminated NCT00319345 - Sodium-Lactate and Traumatic Brain Injury Phase 2/Phase 3
Recruiting NCT04459806 - Intracranial PrEssure Time dOse (ImPETO)
Completed NCT00239525 - 3-D Transcranial Ultrasound Analysis Study N/A
Completed NCT05946200 - Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia N/A
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Not yet recruiting NCT05818371 - Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting N/A
Completed NCT04429477 - Cerebral Compliance Impairment in COVID-19