Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians

Intracranial Hypertension Clinical Trial

— TIMING-ICP  

Official title:

Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045105
• Other study ID #: NP4628
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Intracranial Hypertension

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