Biomedical subjects

G Citerio

Publications and source records attributed to G Citerio.

At least 19 recordsLinked to original sources

PubMed2006

BrainIT: a trans-national head injury monitoring research network.

BACKGROUND: Studies of therapeutic interventions and management strategies on head injured patients are difficult to undertake. BrainIT provides validated data for analysis available to centers that contribute data to allow post-hoc analysis and hypothesis testing. METHODS: Both physiological and intensive care management data are collected. Patient identification is eliminated prior to transfer of data to a central database in Glasgow. Requests for missing/ ambiguous data are sent back to the local center. Country coordinating centers provide advice, training, and assistance to centers and manage the data validation process. RESULTS: Currently 30 centers participate in the group. Data collection started in January 2004 and 242 patients have been recruited. Data validation tools were developed to ensure data accuracy and all analysis must be undertaken on validated data. CONCLUSION: BrainIT is an open, collaborative network that has been established with primary objectives of i) creating a core data set of information, ii) standardizing the collection methodology, iii) providing data collection tools, iv) creating and populating a data base for future analysis, and v) establishing data validation methodologies. Improved standards for multi-center data collection should permit the more accurate analysis of monitoring and management studies in head injured patients.

Biomedical Research↗

PubMed2006

Early stroke care in Italy--a steep way ahead: an observational study.

OBJECTIVES: To measure the performance of selected Italian emergency medical system (EMS) dispatch centres managing calls for patients suffering from stroke. Data on outcome and on early treatment in the ED were collected. METHODS: Prospective data collection for a trimester from interventions for a suspected stroke in 13 EMS dispatch centres over five Italian regions. RESULTS: Altogether, 1041 calls for a suspected stroke were analysed. Mean intervals of the sequential phases were 2.3+/-2 minutes between call and ambulance dispatch, 8.4+/-5.5 minutes to reach the patient, 14.5+/-8.5 minutes on the scene, and 40.2+/-16.2 minutes between call and arrival at the ED. Interventions were performed in 56% of cases by a basic life support (BLS) crew, advanced life support (ALS) crews intervened in 28% of cases, and a combination of ALS and BLS in the remaining 16%. Mean diagnostic interval was 99+/-85 minutes between emergency system call and the first CT scan. This was performed 71+/-27 minutes after ED admission. Only 1.6% were admitted to a stroke unit. One month outcome according to GCS was good recovery in 32%, moderate disability in 28%, severe disability in 14%, and death in 25% of the patients. CONCLUSIONS: Mean times show a rapid response of the selected EMS dispatch centres to calls for a suspected stroke. Nevertheless, mean times of the ED phase are still unacceptable according to international guidelines such as Brain Attack Coalition and American Stroke Association guidelines. Efforts should be spent to reduce the time between the arrival and the CT scan and more patients should be admitted to a stroke unit.

Aged↗

PubMed2006

How to improve ischemic stroke treatment in the fibrinolysis era.

In the last 15 years new therapeutic approaches have influenced the treatment of ischemic stroke victims. Aim of this review is to point out the elements of a modern approach to the acute stroke patient. The likelihood of saving ischemic cerebral tissue is time-dependent and the treatment goal is to minimise brain damage. The NINDS trial has documented a higher likelihood of better outcome if the fibrinolytic therapy is administered within 3 h of onset of symptoms. To reach this target several interventions are necessary. First of all, education is needed to diffuse public awareness of stroke warning signs. Moreover, out-of-hospital treatment should be optimised with rapid triage and transport to an hospital with a comprehensive stroke approach. The early hospital phase should comprehend a rapid evaluation and an urgent CT scan. After the verification of the inclusion/exclusion criteria, in a authorised SITS-MOST centre, the patient should receive fibrinolytic therapy. The diagnostic and the therapeutic phase should include rapid identification and treatment of secondary insults, as hyperthermia and hyperglycaemia, that have a negative influence on outcome. Despite advances in diagnosis and monitoring, fibrinolytic therapy is the only treatment with a proven efficacy in achieving a higher functional outcome. The narrow time-window is the reason for the need of rapid and well-organised out-of-hospital and in-hospital systems.

Brain Ischemia↗

PubMed2005

Continuous cerebral compliance monitoring in severe head injury: its relationship with intracranial pressure and cerebral perfusion pressure.

BACKGROUND: Cerebral compliance expresses the capability to buffer an intracranial volume increase while avoiding a rise in intracranial pressure (ICP). The autoregulatory response to Cerebral Perfusion Pressure (CPP) variation influences cerebral blood volume which is an important determinant of compliance. The direction of compliance change in relation to CPP variation is still under debate. The aim of the study was to investigate the relationship between CPP and compliance in traumatic brain injured (TBI) patients by a new method for continuous monitoring of intracranial compliance as used in neuro-intensive care (NICU). METHOD: Three European NICU's standardised collection of CPP, compliance and ICP data to a joint database. Data were analyzed using an unpaired student t-test and a multi-level statistical model. RESULTS: For each variable 108,263 minutes of data were recorded from 21 TBI patients (19 patients GCS</=8; 90% male; age 10-77 y). The average value for the following parameters were: ICP 15.1+/-8.9 mmHg, CPP 74.3+/-14 mmHg and compliance 0.68+/-0.3 ml/mmHg. ICP was >/=20 mmHg in 20% and CPP<60 mmHg for 10.7% of the time. Compliance was lower (0.51+/-0.34 ml/mmHg) at ICP>/=20 than at ICP<20 mmHg (0.73+/-0.37 ml/mmHg) (p<0.0001). Compliance was significantly lower at CPP<60 than at CPP>/=60 mmHg: 0.56+/-0.36 and 0.70+/-0.37 ml/mmHg respectively (p<0.0001). The CPP - compliance relationship was different when ICP was above 20 mmHg compared with below 20 mmHg. At ICP<20 mmHg compliance rose as CPP rose. At ICP>/=20 mmHg, the relation curve was convexly shaped. At low CPP, the compliance was between 0.20 and 0.30 ml/mmHg. As the CPP reach 80 mmHg average compliance was 0.55 ml/mmHg., but compliance fell to 0.40 ml/mmHg when CPP was 100 mmHg. CONCLUSIONS: Low CPP levels are confirmed to be detrimental for intracranial compliance. Moreover, when ICP was pathological, indicating unstable intracranial equilibrium, a high CPP level was also associated with a low volume-buffering capacity.

Adolescent↗

PubMed2005

Survey of traumatic brain injury management in European Brain-IT centres year 2001.

BACKGROUND: The aim of this study was to obtain basic knowledge about the current local conditions and neurointensive care of traumatic brain injury (TBI) in the new multi-centre collaborative BrainIT group. MATERIALS AND METHODS: The survey comprised a background part on local policies (Part A), and a case study section (Part B). The information was gathered by questionnaire followed by telephone interviews. Twenty-three BrainIT centres participated in the survey and answers from two respondents were available from 18 of the sites. RESULTS: The average proportion of agreement between duplicate respondents was 0.778 (range 0.415-1.00). All BrainIT centres monitored ICP. The treatment protocols seem to have a pattern concerning escalation of treatment of intracranial hypertension: 1/ evacuation of mass lesions and head elevation; 2/ increased sedation and mannitol; 3/ hyperventilation; 4/ ventricular drainage; 5/ craniectomy and barbituates. CONCLUSIONS: There seemed to be an agreement on neurointensive care policies within the BrainIT group. The suggested order of treatment was generally in accordance with published guidelines although the suggested order and combinations of different treatments varied. Variation of treatment within the range of prescribed standards provides optimal conditions for an interesting future analysis of treatment and monitoring data in reality using the BrainIT database.

Brain Injuries↗

PubMed2005

Assessment of the relationship between age and continuous intracranial compliance.

The aim of this open, descriptive and prospective study was to determine if the new monitoring parameter "continuous intracranial compliance (cICC)" decreases with age in patients with traumatic brain injury (TBI). 30 patients with severe and moderate TBI (Glasgow Coma Scale score < or = 10) contributing to a European multicenter study, organized by the Brain-IT group, underwent computerized monitoring of blood pressure, intracranial pressure (ICP), cerebral perfusion pressure and cICC. Regression analyses of individual median ICP and median cICC versus patients' age revealed no significant dependency. Median cICC declined significantly with increasing ICP (when median ICP = 10, 20 and 30 mmHg, cICC = 0.64, 0.56 and 0.42 ml/mmHg respectively, p < 0.05). These three ICP groups were then subdivided according to age (0-20, 21-40, 41-60 and 61-80 years). Median cICC declined with age in both high ICP groups (median ICP = 20,30 mmHg). Percentage cICC values below a set pathological threshold of lower than 0.05 ml/mmHg across the four age groups were 28% (0-20 yrs), 59% (21-40 yrs), 60% (41-60 yrs) and 70% (61-80 yrs) respectively. The observed phenomenon of decreased intracranial volume challenge compensation with advancing age may contribute to the well-known fact of a worse outcome in elderly patients after TBI.

Adolescent↗

PubMed2005

The BrainIT Group: concept and current status 2004.

Brain Injuries↗

PubMed2005

Accurate data collection for head injury monitoring studies: a data validation methodology.

BACKGROUND: BrainIT is a multi centre, European project, to collect high quality continuous data from severely head injured patients using a previously defined [6] core data set. This includes minute-by-minute physiological data and simultaneous treatment and management information. It is crucial that the data is correctly collected and validated. METHODS: Minute-by-minute physiological monitoring data is collected from the bedside monitors. Demographic and clinical information, intensive care management and secondary insult management data, are collected using a handheld computer. Data is transferred from the handheld device to a local computer where it is reviewed and anonymised before being sent electronically, with the physiological data, to the central database in Glasgow. Automated computer tools highlight missing or ambiguous data. A request is then sent to the contributing centre where the data is amended and returned to Glasgow. Of the required data elements 20% are randomly selected for validation against original documentation along with the actual number of specific episodic events during a known period. This will determine accuracy and the percentage of missing data for each record. CONCLUSION: Advances in patient care require an improved evidence base. For accurate, consistent and repeatable data collection, robust mechanisms are required which should enhance the reliability of clinical trials, assessment of management protocols and equipment evaluations.

Brain Injuries↗

PubMed2004

Bench test assessment of the new Raumedic Neurovent-P ICP sensor: a technical report by the BrainIT group.

BACKGROUND: In clinical practice, fiberberoptic and piezo-electric ICP probes are often used for measuring intracranial pressure (ICP). A number of similar technologies, although performing well in bench test studies, have been shown to exhibit unacceptable zero drift, fragility or both during trials conducted under clinical conditions. Recently, a new technology has become available, the Neurovent-P (Raumedic AG + CO, Raumedic, Germany). As a pre-requisite for a clinical trial, we have conducted and report on bench test studies to confirm the manufacturer's long term zero-drift performance for this technology. METHOD: In a test rig static tests (recording of 20 mmHg pressure) and dynamic tests, ranging from 5 to 50 mmHg have been performed. FINDINGS: 10 ICP probes have been tested for a total of 60 days. All the catheters, after the connection with the ICU monitor displayed a static pressure of 0 +/- 1 mmHg and did not required pre-insertion alteration. At five days, mean zero drift was 0.6 +/- 0.9 mmHg. Overall, zero drift ranged from 0 to 2 mmHg. At a fixed static pressure of 20 mmHg, the mean recorded value was 20.6 +/- 0.8 mmHg, ranging from 19 to 23 mmHg. A regression analysis of the relationship between the applied pressure and the recorded pressure during the dynamic tests of the 10 catheters yielded a correlation coefficient R2 of 0.997. Applying the Altman and Bland method to assess the bias and confidence limits for the Raumedic catheter responses during the dynamic tests against the applied gold-standard hydrostatic column pressures, the average bias of -0.66 +/- 0.85 mmHg, with 95% CLs of -2 mmHg and 1 mmHg. CONCLUSIONS: Mean zero drift, after five days, was very small and long-term continuous recording of a stable pressure was very precise. The response at dynamic tests, i.e. the changes of pressure in a wide range, was excellent. The average bias of the Raumedic catheter compared with the hydrostatic column is very small. After this bench test, the next and most critical step will be to conduct a trial of this promising technology under more demanding clinical environment.

Calibration↗

PubMed2004

R3-survey of traumatic brain injury management in European Brain IT centres year 2001.

OBJECTIVE: To obtain knowledge about the conditions and management of traumatic brain injury (TBI) in a collaborative network of Brain Information Technology centres. DESIGN: The Brain IT (Brain monitoring with Information Technology) survey comprised two parts: local conditions and policies (part A), and a case study part (part B). The information was gathered by written questionnaires followed by telephone interviews. PARTICIPANTS: Twenty-four Brain IT centres participated (two respondents from 18 sites). RESULTS: The average proportion of agreement between duplicate respondents was 0.79 (range 0.44-1.00). All Brain IT centres monitored ICP. The reported order of treatment for intracranial hypertension was: evacuation of mass-lesions and head elevation (1), increase of sedation and Mannitol scheme (2), hyperventilation (3), ventricular drainage (4), craniectomy and pentothal coma (5), and decompressive lobectomy (6). The respondents were less prone to evacuate expansive contusions in relation to extra cerebral hematomas. The most common suggested interventions (alone or in combination) for treatment of intracranial hypertension without mass lesions was the Mannitol scheme (included in 71% of the suggestions), CSF drainage (included in 56%), hyperventilation (included in 32%), and pentothal coma (included in 22%). CONCLUSIONS: The suggested management of TBI was mainly in accordance with published guidelines, although a minor proportion of the answers deviated to some extent. The suggested order and combinations of different treatment interventions varied. Variation of treatment within the range of prescribed standards provides optimal conditions for an interesting future analysis of treatment and monitoring data as collected prospectively in a Brain IT database.

Adult↗

PubMed2004

[Moderate hypothermia in traumatic brain injury: results of clinical trials].

The concept of neuroprotection' by hypothermia dates back to ancient times. This paper reviews the results of clinical trials using mild hypothermia (3235 degrees C) in patients with severe traumatic brain injury over the past decade. Induced hypothermia has been used in experimental models mostly to prevent or attenuate secondary neurological injury and has been used to provide neuroprotection in traumatic brain injury, both in animal models and clinical trials. Results from animal experiments largely confirm that hypothermia can provide protection for the injured brain; however, the results from clinical trials and from a number of meta-analyses have been conflicting. This paper reviews the evidence and explores possible reasons for the mixed results from clinical trials. Hypothermia is clearly effective in controlling intracranial hypertension. Early favourable results on neurological outcome and mortality were not confirmed in a subsequent multi-center trial. Subsequently, single-centre studies, with quicker induction of hypothermia and longer duration of cooling, again reported benefits on outcome. These differences may be explained by differences in study protocols (i.e. speed and duration of cooling, speed of re-warming), prevention of side effects and various supportive measures in the ICU. Although induced hypothermia appears to be a highly promising treatment in various forms of neurological injury including traumatic brain injury, the difficulties in realising its therapeutic potential are underscored by the negative results from a large multi-center trial. Routine usage of hypothermia in traumatic brain injury can not currently be recommended.

Brain Injuries↗

PubMed2003

Severe intoxication after phenytoin infusion: a preventable pharmacogenetic adverse reaction.

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Adult↗

PubMed2003

The BrainIT group: concept and core dataset definition.

INTRODUCTION: An open collaborative international network has been established which aims to improve inter-centre standards for collection of high-resolution, neurointensive care data on patients with traumatic brain injury. The group is also working towards the creation of an open access, detailed and validated database that will be useful for post-hoc hypothesis testing. In Part A, the underlying concept, the group coordination structure, membership guidelines and database access and publication criteria are described. Secondly, in part B, we describe a set of meetings funded by the EEC that allowed us to define a "Core Dataset" and we present the results of a feasibility exercise for collection of this core dataset. METHODS: Four group meetings funded by the EEC have enabled definition of a "Core Dataset" to be collected from all centres regardless of specific project aim. A paper based pilot collection of data was conducted to determine the feasibility for collection of the core dataset. Specially designed forms to collect the core dataset demographic and clinical information as well as sample the time-series data elements were distributed by both email and standard mail to 22 BrainIT centres. A deadline of two months was set to receive completed forms back from centres. A pilot data collection of minute by minute physiological monitoring data was also performed. FINDINGS: A core-dataset was defined and can be downloaded from the BrainIT web-site (go to "Core dataset" link at: www.brainit.org). Eighteen centres (82%) returned completed forms by the set deadline. Overall the feasibility for collection of the core data elements was high with only 10 of the 64 questions (16%) showing missing data. Of those 10 fields with missing data, the average number of centres not responding was 12% and the median 6%. An SQL database to hold the data has been designed and is being tested. Software tools for collection of the core dataset have been developed. Ethics approval has been granted for collection of multi-centre data as part of a pilot data collection study. INTERPRETATION: The BrainIT network provides a more standardised and higher resolution data collection mechanism for research groups, organisations and the device industry to conduct multi-centre trials of new health care technology in patients with traumatic brain injury.

Brain Injuries↗

PubMed2003

Treatment of fever in neurosurgical patients.

Even moderate temperature elevations soon acute cerebral damage may markedly worsen initial brain injury. These effects may justify aggressive antipyretic treatment in neurosurgical intensive care unit (NICU). On the basis of a literature survey, it is observed that fever is extraordinarily common in the neurosurgical intensive care unit during the acute phase of subarachnoid hemorrhage, stroke, and traumatic brain injury. Several clinical studies also suggest worsened neurologic outcome in patients who are febrile compared to those who are not. Pyrexia is more frequent in infected than noninfected patients. Infections (mainly in the respiratory tract) are usually diagnosed in the majority of febrile NICU patients. Laboratory investigations are quite clear regarding the adverse effects of fever in terms not only of functional outcomes, but also histological and neurochemical injury. Even though fever may cause diagnostic confusion (central fever vs infectious), the potentially devastating effects of pyrexia in patients with cerebral diseases may proceed to treat in any case. An attempt to correct fever appears warranted in all patients with acute cerebral damage in order to obtain a better functional recovery and to limit maximally any further insult to the brain. Some of the more common and innovative methods to control body temperature in order to mitigate the detrimental effects of pyrexia following acute neurological injury are explored. Maintenance of normothermia appears to be a desirable therapeutic goal in managing the patients with damaged or at-risk brain tissue. However, it has not been established conclusively that the benefits of antipyretic therapy outweigh its risks and that despite a sound physiologic argument for controlling fever in the brain-injured patient, there is no evidence that doing so will improve their outcome.

Brain Injuries↗

PubMed2003

[Neuro-link, an Italian traumatic coma data bank: what did we learn from the first 1000 patients and how can we do better? ].

To understand the complex physiopathology of post-traumatic brain damage is important to have data on epidemiology, clinical course, monitoring, effect of therapy and outcomes. In 1997 3 neuro-intensive care units in the Milan metropolitan area developed a computer assisted database named Neuro-Link (NL) for collection of information on head injury. All head injured patients requiring intensive care during the first 24 hours post-trauma were eligible. The data collection form was designed for use with a computer interface to cover: 1) general, previous and admission data; 2) secondary insults and complication; 3) CT scan and monitoring data; 4) outcome data. Two different data collections were performed: 1) NL domestic (data from 3 centres from 1997); 2) NL 18 centres (3 month survey of Italian centres with interest in neurotrauma care). An audit of the data was performed. NL domestic included 1 085 patients from 1997 to 2002. NL 18 centres included 282 patients in the 3 month period. Audit is performed on 35 000 data per year.A large number of good quality information on head injury patients is now available. The database is useful for: 1) production of information; 2) base for prospective studies.

Coma↗

PubMed2002

Multi-centre assessment of the Spiegelberg compliance monitor: interim results.

Analyses of a multi-centre database of 71 patients at risk of raised ICP showed that in head injured patients (n = 19) and tumour patients (n = 13) clear inverse relationships of ICP vs compliance exist. SAH patients (n = 5) appear to exhibit a biphasic relationship between ICP and compliance, however greater numbers of patients need to be recruited to this group. Patients with hydrocephalus (n = 34) show an initial decrease in compliance while ICP is less than 20 mmHg, thereafter compliance does not show a dependence upon ICP. A power analysis confirmed that sufficient numbers of patients have been recruited in the hydrocephalus group and a ROC analysis determined that a mean compliance value of 0.809 (lower and upper 95% CL = 0.725 & 0.894 resp.) was a critical threshold for raised ICP greater than 10 mmHg. Preliminary time-series analyses of the ICP and compliance data is revealing evidence that the cumulative time compliance is in a low compliance state (< 0.5 ml/mmHg), as a proportion of total monitoring time, increases more rapidly than the cumulative time ICP is greater than 25 mmHg. Before trials testing compliance thresholds can be designed, we need to consider not just the absolute threshold, but the duration of time spent below threshold. A survey may be required to identify a consensus of what is the minimum duration of raised ICP above 25 mmHg needed to instigate treatment.

Automation↗

PubMed2002

Continuous cerebral compliance monitoring in severe head injury: its relationship with intracranial pressure and cerebral perfusion pressure.

Cerebral Compliance describes the ability of cranial content to accommodate volume variations. Intracranial vascular compartment is thought to be one of the most important determinants of Compliance. Cerebral perfusion pressure (CPP) has a significant influence upon the calibre of cerebral vessels and consequently, upon blood volume. This study was designed to investigate the influence of CPP on intracranial volumes balance, described by cerebral compliance, in severe traumatic brain injured patients (TBI). Nine TBIs were studied. The Spiegelberg ventricular catheter continuously measured ICP and Compliance. Compliance, CPP and ICP were digitally collected for a total of 737 hours of monitoring (44239 total data). Compliance was lower at CPP < 60 than at CPP > or = 60 (0.51 +/- 0.3 versus 0.64 +/- 0.3 ml/mmHg). The ICP level influenced the relation between CPP and Compliance. At ICP < 20 (LICP; 80.3% of data) Compliance and CPP were not significantly related. At ICP > or = 20 mmHg (HICP; 19.7% of data), Compliance varied with changes in CPP. When CPP < 60 mmHg, Compliance showed a trend to decrease as CPP decreased (R2 = 0.85). At CPP > or = 60 mmHg Compliance decreased with CPP (R2 = 0.83). In the range of low CPP vasoparalysis is impending. However, when ICP is pathological, at high CPP our results may express vasodilatation instead of expected vasoconstriction from normal autoregulation.

Adolescent↗

PubMed2002

Emergency system prospective performance evaluation for cardiac arrest in Lombardia, an Italian region.

BACKGROUND: The aim of this research is to evaluate quality of out-of-hospital medical services in our country, using performance indicators and a new computerised database. METHODS: (a) EXPERIMENTAL DESIGN: Data were collected prospectively in three emergency dispatch centres for 90 days. Follow-up was evaluated at 1 day and 1 month after the event. This paper presents data on the cardiac arrest cohort only. (b) SETTING: Three emergency dispatch centres in Lombardia. (c) PATIENTS: One hundred and seventy-eight patients in non-traumatic cardiac arrest were enrolled. (d) INTERVENTIONS: None. The study was observational only. RESULTS: Mean interval between phone call and arrival on scene was 8.5+/-3.5 min. BLS manoeuvres were carried out from bystanders only in 15% of the cohort; this was associated with significant mortality reduction (85.7 versus 95.8%, chi(2) P<0.05). One hundred and thirty-three patients (75%) received assistance from BLS crews while only 45 patients (25%) were assisted by ALS medical personel, with a significant mortality reduction (ALS deaths 86.7%, BLS deaths 97%). Total 24 h survival was 9% and survival at 1 month declined to 6.17%. CONCLUSIONS: Quality monitoring produces objective information on interventions and outcomes. Only with this information, is it possible to implement improvement programmes that are planned according to the data presented.

Aged↗