Mental Health
Conditions
Keywords
Electrical storm, Ventricular tachycardia, Dexmedetomidine, Mental health
Brief summary
The goal of the research study is to measure mental health and quality of life indices of individuals treated for electrical storm (ES). The consequences of being admitted to an intensive care unit (ICU) with electrical storm as well as the treatments patients would have received, are currently not well understood. Understanding the mental health burden of these treatments among survivors can provide insights into how to improve care. This is a study consisting of patients who participated in the SEDATE trial (dexmedetomidine vs usual standard of care to treat ES in the ICU). Patients who consent to participate in this study will be asked to complete a set of questionnaires 3-6 months after their ICU admission. The purpose of the questionnaires is to measure indices of mental health and health-related quality of life. Each questionnaire will take about 5-15 minutes to complete. If patients have a scheduled follow-up at the University of Ottawa Heart Institute, a member of the research team will meet with them during their clinic visit to complete the questionnaires. Otherwise, they can be completed over the telephone.
Interventions
DRUGDexmedetomidine
Dexmedetomidine infusion during ICU admission for electrical storm
DRUGPlacebo
Placebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients admitted to an intensive care unit with a diagnosis of electrical storm within the preceding 6 months * Previous participants in the SEDATE trial (NCT06281977)
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic stress disorder symptoms | Assessed 3-6 months after hospitalization for electrical storm | Post-traumatic stress disorder (PTSD) checklist (PCL-5) score. Respondents are asked to rate the presence and severity of various symptoms in the preceding month on 5-point Likert scale. A higher score indicates worse symptoms. A cumulative cut-off score of 31-33 is usually considered indicative of probable PTSD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety symptoms | Assessed 3-6 months after hospitalization for electrical storm | General Anxiety Disorder 7-item (GAD-7). This is a screening tool for the presence and measure of the severity of anxiety symptoms. A higher score suggests more severe symptoms |
| Depression symptoms | Assessed 3-6 months after hospitalization for electrical storm | Patient Health Questionnaire-9 (PHQ-9). This is a screening tool for the presence and measure of the severity of depression symptoms. A higher score suggests more severe symptoms. |
| Anxiety/fear relating to implantable cardioverter-defibrillator shocks | Assessed 3-6 months after hospitalization for electrical storm | Florida Shock Anxiety Scale (FSAS). This is a measure of patient anxiety/fear relating to implantable cardioverter-defibrillator shocks. A higher score suggests more shock-related anxiety |
| Quality of life measure | Assessed 3-6 months after hospitalization for electrical storm | Quality of life measurements, as obtained through use of the 36-Item Short Form Survey Instrument (SF-36), a validated questionnaire tool to measure health-related quality of life/health status across specific domains. A higher score indicates better self-reported health |
Countries
Canada
Contacts
CONTACTF Daniel Ramirez, MD MSc FRCPC
Outcome results
None listed