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

NCT05045105 | Unknown

• 1 other identifier: NP4628
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 18

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.

Conditions

Intracranial Hypertension; Timing of Invasive Intracranial Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparative evaluation of post-procedural complications between intensivists and neurosurgeons

  procedure to hospital discharge (in case of malfunction of the catheter, time is up to 12 hours after placement)

• Length of ICU stay

  ICU admission to discharge, up to 30 days

• length of hospital stay

  hospital admission to discharge, up to 30 days

• duration of mechanical ventilation

  from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days.

• Glasgow Outcome Score at 3 months

  3 months after the acute event

Study Arms (2)

ICU physicians

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

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

Interventions

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.

Also known as: Complications related to the maneuver between the two cohorts

ICU physicians; Neurosurgeons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All acute brain Injured patients with urgent indication for invasive intracranial pressure monitoring

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (18)

Ospedale "M. Bufalini", Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)

Cesena, Forlì-Cesena, 47521, Italy

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale Ovest Milanese (Neurosurgery Unit)

Legnano, Milano, 20025, Italy

NOT YET RECRUITING

Ospedale Papa Giovanni XXIII, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)

Bergamo, 24127, Italy

NOT YET RECRUITING

Spedali Civili di Brescia, Neurosurgery Unit (U.O. Neurochirugia)

Brescia, 25123, Italy

RECRUITING

Spedali Civili, Neuro Critical Care Unit (U.O. Anestesia e Rianimazione 2)

Brescia, 25123, Italy

RECRUITING

Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta (Neurosurgery Unit)

Caserta, 81100, Italy

NOT YET RECRUITING

Ospedale Sant'Anna di Como, Intensive Care Unit (U.O. Anestesia e Rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)

Como, 22100, Italy

NOT YET RECRUITING

Ospedale Policlinico San Martino (Neurosurgery Unit)

Genova, 16132, Italy

NOT YET RECRUITING

Ospedale Santa Maria Goretti (Neurosurgery Unit)

Latina, 04100, Italy

NOT YET RECRUITING

Ospedale A. Manzoni (Intensive Care Unit and Neurosurgery Unit)

Lecco, 23900, Italy

NOT YET RECRUITING

Ospedale Civile di Baggiovara (Neurosurgery Unit)

Modena, 41126, Italy

NOT YET RECRUITING

Ospedale Santa Maria di Loreto Nuovo, Intensive Care Unit (U.O.C. di Terapia Intensiva e Rianimazione), Neurosurgery Unit (U.O.C. Neurochirurgia)

Napoli, 80142, Italy

NOT YET RECRUITING

Azienda Ospedale Università Padova (Neurosurgery Unit)

Padua, 35128, Italy

NOT YET RECRUITING

Policlinico San Matteo, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)

Pavia, 27100, Italy

NOT YET RECRUITING

Policlinico Universitario Agostino Gemelli (Neurosurgery unit)

Roma, 00168, Italy

NOT YET RECRUITING

Azienda Ospedaliera Città della Salute e della Scienza, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)

Torino, 10126, Italy

NOT YET RECRUITING

Presidio Ospedaliero Universitario Santa Maria della Misericordia, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit

Udine, 33100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona (Neurosurgery Unit)

Verona, 37126, Italy

NOT YET RECRUITING

Related 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. doi: 10.1385/NCC:4:1:008.

  PMID: 16498188 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.

  PMID: 18826355 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.

  PMID: 23055087 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.

  PMID: 14501890 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.

  PMID: 18449808 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.

  PMID: 22929484 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.

  PMID: 23473439 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Frank Rasulo

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank A Rasulo

CONTACT

+39 3393366290; frank.rasulo@gmail.com

Giovanni Chiarini

CONTACT

+39 3473926790; giovanni.chiarini88@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: September 16, 2021
• Study Start: April 27, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

IT (18)