Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care (STANDAREA)
|Study Design:||Observational Model: Cohort|
|Official Title:||Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing|
- rate of inhalation pneumonia [ Time Frame: 26 months ] [ Designated as safety issue: No ]
- occurrence of ventilatory disorders [ Time Frame: 26 months ] [ Designated as safety issue: No ]
- presence of shock and premature death of the patient. [ Time Frame: 26 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Included patients have been no specific nursing practice.
Standardization of nursing supervision of included patients using a grid of appropriate surveillance for the prevention of complications in the ICU
As part of improving the quality of care, the paramedic team has developed an evaluation grid quantitative parameters of the early warning score, the Glasgow Coma Score modified and signs suggestive of hepatic encephalopathy.A course of action was later formalized as a function of score when using the grid monitoring.
The aim of the study is to demonstrate that the standardization of monitoring by a quantitative evaluation grid reduces the complications of hepatic encephalopathy. For this, investigator's team will study a before / after standardization by comparing two groups of patients, ICU liver - digestive BEAUJON hospital, and suffering from hepatic encephalopathy associated with liver cirrhosis and therapeutic care project formalized. For the first group have been no specific nursing practice, investigator's team will take a retrospective study. For the second group have been monitoring a standard, investigator's team will take a prospective study.
The total number of patients in each group will be 121 a total of 242. The frequency of pneumonia is the primary outcome. Secondary endpoints were the occurrence of ventilatory disorders, the presence of shock and premature death of the patient during his hospitalization. investigator's team will compare the frequency of occurrence of these complications in both groups.
Data will be collected using a questionnaire based on information from the software and GILDAE DXCARE.
The prospective study will last 26 months. For the retrospective study, the MSI will publish a list of all patients meeting the inclusion criteria and ICU liver - digestive in the 26 months preceding the start of the study.
The interest of this work is to formalize an objective tool for assessing hepatic encephalopathy and improve communication among caregivers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494064
|Clichy, France, 92110|
|Study Director:||Isabelle Villard||Assistance Publique - Hôpitaux de Paris|