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Costs and effects of strategies to prevent oversedation in Intensive Care patients.

Randomized trial comparing the effects of BIS monitoring and daily wake up with clinical assessment on ICU length of stay and costs in sedated ICU patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21083
Enrollment
600
Registered
2005-08-14
Start date
2004-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients requiring continuous intravenous sedation.

Interventions

Patients will be randomised to one of the following three arms of the trial: 1. Continuous infusion of sedative agents and clinical assessment of the level of sedation with BIS monitoring (index grou
2. Daily interruption of sedative infusions (index group 2)
3. Continuous infusion of sedative agents and clinical assessment of the level of sedation (reference group).

Sponsors

Academisch Medisch Centrum Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consecutive ICU patients who are 18 years or older; 2. Patients who are sedated for less than 24 hours; 3. Patients who are expected to need sedation for at least another day.

Exclusion criteria

Exclusion criteria: 1. Patients who have been transferred from another ICU where sedative agents have been administered for more than 24 hours; 2. Patients with a decreased level of consciousness (defined as a Glasgow Coma Scale score of 12 or lower immediately before sedatives were administrated), will also be excluded; 3. Patients with an acute cerebral disease in whom the level of consciousness may decrease during admission.

Design outcomes

Primary

MeasureTime frame
Duration of ICU stay, which is used as an inverse indicator of patient safety.

Secondary

MeasureTime frame
1. The duration of mechanical ventilation; 2. The number and type of accidentally removed catheters; 3. The use and type of additional diagnostic tests to evaluate possible oversedation; 4. The number of re-admissions to the ICU; 5. The length of hospital stay; 6. The score on the questionnaire on stressful events (Rotondi); 7. Cumulative survival from admission to the ICU until three months; 8. Direct, medical costs of used health care resources and indirect, non-medical costs of lost productivity.

Contacts

Public ContactM.B. Vroom

Academic Medical Center (AMC), Intensive Care Adults (C3-423), P.O. Box 22660

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)