None listed
Conditions
Brief summary
Continuous infusions of sedatives are commonly used in Australian Intensive Care Units (ICUs) to provide patient comfort and promote tolerance of ICU treatment. These infusions are occasionally stopped to allow patients to return to consciousness to enable assessment of their neurological function and sedation requirements. A routine daily interruption to sedation has been recommended as a standard of care in ICU patients (Dellinger, Crit Care Med, 2004). This recommendation is based on the work of Kress (NEJM, 2000) who enrolled 180 patients in a medical ICU in Chicago. Several aspects of this work significantly reduce the appropriateness of generalising these results to Australian ICU practice. Fully exploring the impact of a daily interruption to sedation is warranted in the context of Australian ICU practice prior to its adoption as a standard of care. In this pilot study, the standard practice of interruption to sedation on an ad-hoc basis will be compared to a routine interruption to sedation for a defined period each day in Australian ICUs. These comparisons will be based on the length of time that mechanical ventilation, ICU and hospital treatment is required and psychological well being 6 months after discharge from ICU. All patients enrolled in the study will be given an infusion replacing their prescribed sedation for a defined period each day. The replacement infusions will be either normal saline or identical to the patients prescribed sedation. This pilot study will test the proposed blinding procedures and facilitate an appropriate power calculation.
Interventions
Every patient enrolled in the study will have their prescribed sedation ceased, and a replacement infusion started at 9am each morning. Patients randomised to the intervention group will receive a replacement infusion of normal saline and thus have their continuous sedative infusions interrupted each day. The duration of replacement infusion for both groups will be dependant on patient response during the replacement infusion which is to run for a maximum of 6 hours. Patients will have their r
Every patient enrolled in the study will have their prescribed sedation ceased, and a replacement infusion started at 9am each morning. Patients randomised to the intervention group will receive a replacement infusion of normal saline and thus have their continuous sedative infusions interrupted each day. The duration of replacement infusion for both groups will be dependant on patient response during the replacement infusion which is to run for a maximum of 6 hours. Patients will have their replacement infusion ceased and be returned to their prescribed sedative infusion should they experience increasing levels of discomfort, pain or agitation or at 3pm each afternoon, which ever comes first.
Sponsors
Department of Critical Care Medicine, Nepean Hospital.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Predicted to require treatment via continuous infusion of sedation to tolerate mechanical ventilation for greater than 48 hours.
Exclusion criteria
Admitted for treatment of neurological or neurosurgical diagnosis. Under the care of a mental health team.
Outcome results
None listed