| Trial name or title |
Impact of non‐pharmacological prevention measures on the incidence of delirium in adult ICUs (DELIREA)
Country: France |
| Methods |
Parallel assignment multicentre RCT (14 centres) |
| Participants |
Adults. Expected n = 952 |
| Interventions |
Intervention
Bundle: awakening and breathing co‐ordination delirium monitoring and management (detection and management of delirium), early mobility, factors of environment, thirst, noise, pain and well‐being, sleep and isolation.
Control
Standard paramedical and medical practices. The hypothesis is that a set of co‐ordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.
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| Outcomes |
Incidence rate of delirium within 60 days Duration of delirium between the diagnosis and the resolution of delirium The duration of delirium (in days) between the diagnosis and the resolution of delirium will be done until 60 days of the stay of the patients in intensive care Evaluation of cognitive and psycho‐behavioral functions: memory: test of 5 words and free recall test; executive: fast evaluation battery for executive functions, trail‐making test, digit span, Stroop and verbal fluences and animals), praxis : Mahieux's test; language: D0 80; behaviour: Montgomery's scale (depression), Starkstein's scale (apathy) QoL (short form 36 item) within 12 months
Assessment will be by CAM‐ICU |
| Starting date |
27 October, 2016, expected completion April 2019 |
| Contact information |
Stein Silva MD silva.s@chu‐toulouse.fr |
| Notes |
Study number: NCT03125252
Status: recruiting
Contact with author: email sent 14 June 2017 inquiring of study status ‐ awaiting response |
