Delirium Clinical Trial
Official title:
Delirium in Patients Admitted to a Respiratory Weaning Centre: Analysis of Incidence and Risk Factor
Delirium is rather common among patients in Intensive Care Units (ICU), while little is known about its incidence in ventilator-dependent patients transferred to a Weaning Center (WC), once in a phase of clinical stability. We will prospectively evaluate for the presence of delirium all the ventilator-dependent patients admitted to our WC over a period of two years. They will be monitored using the Intensive Care Delirium Screening Checklist (ICDSC), previously validated in the ICU setting. This evaluation is based on a score based on 8 items obtained with a simple examination by the attending physician. The final sum generates a score considered normal (0-1), borderline (2-3) and pathologic (>4). All the patients, except those with normal score, will also be evaluated by a psychiatrist, using the Diagnostic Manual of Mental Disorders (DSM-IV), considered the gold standard. The score will be assessed at patient's admission, at mid-hospital stay and at discharge.
Delirium has been defined, according to the Diagnostic and Statistical Manual of Mental
Disorders (DSM IV), as a disturbance of consciousness characterized by an acute onset and
fluctuating course. This impairment of cognitive functions, not being accounted for by a
pre-existing dementia, reduces the patient's ability to receive, process and recall
informations and its main features are inattention, disorganized thinking and reduced
clarity of awareness of the environment.
All patients transferred from an intensive care unit to our respiratory weaning centre (RWC)
will be screened for the occurrence of delirium. Our RWC is a 7-bed unit located within the
respiratory department of a rehabilitation hospital and is fully equipped for invasive and
non-invasive mechanical ventilation (MV) and for invasive and noninvasive cardiorespiratory
monitoring. Patients are generally transferred to our unit from a general or surgical ICU
for weaning from MV or, in case of patients already weaned, for rehabilitation, monitoring
and intensive nursing care. All patients or their next of kin will give written informed
consent to participate to the study and the study protocol has been approved by the local
ethics committee.
For the assessment of delirium we use the Intensive Care Delirium Screening Checklist
(ICDSC),a diagnostic tool already validated in the intensive care setting even in
mechanically ventilated patients. It is based on the assessment of 8 different items dealing
with the patient's mental status: each one is scored 0 or 1 in case of, respectively,
absence or presence of the item itself and the final score is the resultant of the sum of
the different items (see the appendix 1 for further details). The evaluation is performed on
a daily basis by the physician in charge and the ICDSC score is ranked in the following way:
0 to 1 is considered normal, 2 to 3 is considered borderline, (i.e. indicative of a
subsyndromal delirious state) and 4 or greater is considered diagnostic for delirium (13).
In presence of a score greater than 1 the psychiatrist is called for consultation and
diagnostic confirmation. Upon discharge of the patient from our RWC a score trend is drawn
for every patient using the three highest scores sampled during the phases of admission, of
mid stay and of discharge. Cases of overt delirium (only patients with ICDSC score ≥4) are
categorized as hyperactive or hypoactive, according to a currently accepted classification.
Treatment of delirium, when properly diagnosed, is instituted according to the psychiatist's
prescriptions.
Patient's data collection include demographic data (age, gender), severity score (SAPS II),
reason for admission (i.e. need for mechanical ventilation (MV) or not (NMV)) and previous
episodes of delirium (hyperactive forms) occurring during ICU stay not linked to a
pre-existing mental disease or to an acquired brain failure of vascular, metabolic or
infectious origin. The Kelly scale is used for the assessment of the level of consciousness:
the patient is considered comatose in presence of a persistent (>24 hours) Kelly score of
≥4. As far as the use of sedatives and analgesics in our RWC is concerned, our policy is
based on the avoidance of continuous infusions regimens and on the limitation to the use of
those drugs with a known or suspected capability to induce delirium; each drug is prescribed
when strictly needed according to the judgement of the physician on duty and is targeted to
the treatment of the specific symptom: pain, anxiety, insomnia etc.
Analysis of variance for repeated measures (MANOVA) is employed for statistical analysis,
and a p value lower than 0.05 is considered the threshold value for statistical
significance.
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Observational Model: Cohort, Time Perspective: Prospective
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