Self-management of Sedative Therapy by Ventilated Patients
Summary
The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support. The investigators hypothesis is that self-management of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU), tailored to their individual needs will be more efficacious than nurse-administered sedative therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and occurrence of delirium.
Timeline
- Start
- 2016-11
- Primary completion
- 2024-10
- Completion
- 2024-12
Outcome
Mixed primary results
registry analysis (superiority test); Control vs Dexmedetomidine; p = 0.30; Generalized estimating equations NCT02819141 ↗
registry MEAN Control: 68.7 (Standard Deviation 58.2) hours NCT02819141 ↗
registry MEAN Dexmedetomidine: 50.3 (Standard Deviation 52.8) hours NCT02819141 ↗
registry analysis (superiority test); Control vs Dexmedetomidine; p = 0.02; t-test, 1 sided; note: a priori threshold for significance p \< 0.05. NCT02819141 ↗
registry analysis (superiority test); Control vs Dexmedetomidine; p = 0.97; Generalized estimating equations NCT02819141 ↗
Publications
- Background Tracy MF, Chlan L, Savik K, Skaar DJ, Weinert C. A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients. Nurs Res. 2019 Jan/Feb;68(1):73-79. doi: 10.1097/NNR.0000000000000322.
- Background Chlan LL, Weinert CR, Tracy MF, Skaar DJ, Gajic O, Ask J, Mandrekar J. Study protocol to test the efficacy of self-administration of dexmedetomidine sedative therapy on anxiety, delirium, and ventilator days in critically ill mechanically ventilated patients: an open-label randomized clinical trial. Trials. 2022 May 16;23(1):406. doi: 10.1186/s13063-022-06391-w.
- Background Chlan LL, Tracy MF, Ask J, Lal A, Mandrekar J. The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team's experience. Trials. 2023 May 11;24(1):321. doi: 10.1186/s13063-023-07355-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | — | Intravenous |