Enteral versus intravenous approach for the sedation of critically ill patients: a randomized and controlled trial.

BACKGROUND: ICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation. METHODS: This was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality. RESULTS: There were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01). CONCLUSIONS: Although enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01360346 . Registered on 25 March 2011.

A family information brochure and dedicated website to improve the ICU experience for patients' relatives: an Italian multicenter before-and-after study.

PURPOSE: Good communication between ICU staff and patients' relatives may reduce the occurrence of post-traumatic stress disorder, anxiety or depression, and dissatisfaction with clinicians. An information brochure and website to meet relatives' needs were designed to explain in technical yet simple terms what happens during and after an ICU stay, to legitimize emotions such as fear, apprehension, and suffering, and to improve cooperation with relatives without increasing staff workload. The main outcomes were improved understanding of prognosis and procedures, and decrease of relatives' anxiety, depression, and stress symptoms. METHODS: In this prospective multicenter before-and-after study, a self-administered questionnaire was used to investigate relatives' understanding of prognosis, treatments, and organ dysfunction, families' satisfaction, and symptoms of anxiety, depression, and post-traumatic stress. RESULTS: A total of 551 relatives received questionnaires in nine Italian ICUs; 332 (60%) responded, 144 before and 179 after implementation of the brochure and website. Of the 179 relatives who responded after, 131 (73%) stated they had read the brochure and 34 (19%) reported viewing the website. The intervention was associated with increased correct understanding of the prognosis (from 69 to 84%, p = 0.04) and the therapeutic procedures (from 17 to 28%, p = 0.03). Multivariable analysis, together with non-modifiable factors (relative's gender, education level, relationship to patient, and patient status at ICU discharge), showed the intervention to be significantly associated with a lower incidence of post-traumatic stress symptoms (Poisson coefficient = -0.29, 95% CI -0.52/-0.07). The intervention had no effect on the prevalence of symptoms of anxiety and depression. CONCLUSION: An information brochure and website designed to meet relatives' needs improved family members' comprehension and reduced their prevalence of stress symptoms.

Specificity and reliability of prognostic indexes in intensive care evaluation: the spontaneous cerebral haemorrhage case.

OBJECTIVE: To determine the reliability of a generic index such as Simplified Acute Physiology Score II (SAPSII), compared with a specific one Intra Cerebral Haemorrhage score (ICH score), as an intensive care unit (ICU) outcome predictor when evaluating a general facility that frequently treats a specific type of patients - those with spontaneous cerebral haemorrhage. METHODS: The study cohort consisted of a random sample of patients (81) admitted to Modena's Policlinico Teaching Hospital's ICU with spontaneous ICH over a 24-month period. Main outcome measure SAPSII, ICH score, overall mortality. RESULTS: The mean ICH score for the 32 surviving patients was 3.41 +/- 1.012 while for the 49 deceased patients was of 4.24 +/- 0.855 (P = 0.000). The mean SAPSII value for the 32 surviving patients was 49.09 +/- 16.58 while for the 49 deceased patients was 49.51 +/- 15.93. SAPSII, ICH scores were analysed for mortality, by receiver operating characteristic curves: the area under the curve was significant for ICH, not-significant for SAPSII. CONCLUSIONS: Regional quality controls use generic prognostic indexes (SAPSII) in relation to mortality and outcome to assess ICUs, which is appropriate when dealing with a general facility when there is not a predominant type of patient, but it may bias the evaluation if the population with specific pathologies (ICH), not included in the general index, is statistically considerable, leading to an incorrect criticality assessment, an inappropriate strategic plan and the subsequent inefficient resource allocation.

Heat wave in Italy and hyperthermia syndrome.

In the city of Modena, Italy, daily temperatures registered during the year 2003 showed a higher mean increase of 3 degrees C compared with the previous three years, with average temperature of 26.1 degrees C, compared with 22.8 degrees C. The reported ambient temperature was higher than 32.3 degrees C in 84% of the recorded days, and daily values exceeded 35.1 degrees C in 62% of the days. During the summer, four heat waves occurred (June 11-15, July 21-23, August 3-15 and August 17-24). Nine patients affected by hyperthermia syndrome with a mean body temperature of 41.4 +/- 1.3 degrees C were admitted to the Intensive Care Unit (ICU) of the Modena Teaching Hospital. Another patient with similar clinical features was not admitted to ICU, but to a general ward, and eventually died a few hours later. Mortality reached 80% and the mean survival time was 4.2 days with median values of one day. All patients except for one were admitted during one of the four above-mentioned heat waves, and in particular, 7 patients were admitted during the period from August 3rd to 15th. A common feature among 8 of the 10 patients was the chronic consumption of psychoactive drugs. According to these observations, it is important to identify a population at risk in case of bioclimatological alarm, to find prevention strategies. It is extremely important in patients with hyperthermia to lower body temperature levels in the early hours to influence the malignant evolution of this severe pathologic process.