Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians (TIMING-ICP)

September 6, 2021 updated by: Dr. Frank Rasulo, Università degli Studi di Brescia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Ospedale Papa Giovanni XXIII, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)
        • Contact:
      • Brescia, Italy, 25123
      • Brescia, Italy, 25123
      • Caserta, Italy, 81100
        • Not yet recruiting
        • Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta (Neurosurgery Unit)
        • Contact:
      • Como, Italy, 22100
        • Not yet recruiting
        • Ospedale Sant'Anna di Como, Intensive Care Unit (U.O. Anestesia e Rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)
        • Contact:
      • Genova, Italy, 16132
        • Not yet recruiting
        • Ospedale Policlinico San Martino (Neurosurgery Unit)
        • Contact:
      • Latina, Italy, 04100
        • Not yet recruiting
        • Ospedale Santa Maria Goretti (Neurosurgery Unit)
        • Contact:
      • Lecco, Italy, 23900
        • Not yet recruiting
        • Ospedale A. Manzoni (Intensive Care Unit and Neurosurgery Unit)
        • Contact:
      • Modena, Italy, 41126
      • Napoli, Italy, 80142
        • 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)
        • Contact:
      • Padova, Italy, 35128
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Policlinico San Matteo, Intensive Care Unit (U.O. Anestesia e rianimazione 2), Neurosurgery Unit (U.O. Neurochirurgia)
        • Contact:
      • Roma, Italy, 00168
        • Not yet recruiting
        • Policlinico Universitario Agostino Gemelli (Neurosurgery unit)
        • Contact:
      • Torino, Italy, 10126
        • Not yet recruiting
        • Azienda Ospedaliera Città della Salute e della Scienza, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)
        • Contact:
      • Udine, Italy, 33100
        • Not yet recruiting
        • Presidio Ospedaliero Universitario Santa Maria della Misericordia, Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit
        • Contact:
      • Verona, Italy, 37126
    • Forlì-Cesena
      • Cesena, Forlì-Cesena, Italy, 47521
        • Not yet recruiting
        • Ospedale "M. Bufalini", Intensive Care Unit (U.O. Anestesia e Rianimazione), Neurosurgery Unit (U.O. Neurochirurgia)
        • Contact:
    • Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Complications related to the maneuver between the two cohorts
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
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.
Other Names:
  • Complications related to the maneuver between the two cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare timing of invasive intracranial pressure monitoring performed by intensive care physicians and neurosurgeons
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative evaluation of post-procedural complications 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)
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)
Length of ICU stay
Time Frame: ICU admission to discharge, up to 30 days
Length of ICU stay
ICU admission to discharge, up to 30 days
length of hospital stay
Time Frame: hospital admission to discharge, up to 30 days
length of hospital stay
hospital admission to discharge, up to 30 days
duration of mechanical ventilation
Time Frame: from initiation of mechanical ventilation to weaning from the ventilator, 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
Time Frame: 3 months after the acute event
Glasgow Outcome Score
3 months after the acute event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • Principal Investigator: Frank Rasulo, Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Anticipated)

May 3, 2022

Study Completion (Anticipated)

May 3, 2022

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP4628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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