A Pilot Study of Stellate Ganglion Blockade + Psychoeducation to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Proportion of Participants Who Complete the 12-weeks Assessments
研究概览
简要总结
This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA).
Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms.
Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.
详细描述
Every year in the U.S., 500,000 people experience sudden cardiac arrest (CA), caused by electrical disturbances across cardiac tissue, leading to marked arrhythmia that ultimately results in the heart ceasing to pump blood to the brain, lungs, and other organs. Due to advances in bundled post-arrest care, cardio-cerebral resuscitation, and effective cooling protocols, a substantial proportion of patients who receive guideline-based care (nearly 1 in 3 for out-of-hospital and ~50% for in-hospital CA) now survive this once universally fatal condition. While most survivors retain their cognitive function and physical independence, many grapple with CA's psychological consequences in the context of learning that they were "clinically dead."
In particular, many describe the CA experience as traumatic, and up to 1 in 3 CA survivors subsequently develop posttraumatic stress disorder (PTSD). Not only is PTSD common in CA patients, but there is evidence that PTSD after CA may influence health behaviors and prognosis.
Treatment of early PTSD and cardiac anxiety symptoms after CA requires timely intervention. Recent studies show that SGB is a safe and acceptable intervention for reducing PTSD symptoms in combat veterans. SGB treatment has never been tested to treat PTSD induced by acute medical events such as CA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In addition to the unblinded coordinator, and due to the nature of the study treatment, the person performing the procedure cannot be blinded (i.e. the person performing the procedure needs to assess the effectiveness of the block objective physical signs and symptoms), but is encouraged not to disclose the allocation to the patient or outcome assessors either before or after the procedure.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of Participants Who Complete the 12-weeks Assessments
时间窗: 12-weeks post-procedure
This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.
Treatment Expectancy Eligibility Questionnaire
时间窗: Immediately post-procedure
This is a questionnaire that assesses the number of participants with credibility. Through this questionnaire, whether the participant will proceed through the study will be determined.
Proportion of Eligible Subjects Who Get Enrolled in the Trial
时间窗: Baseline (pre-procedure)
This is designed to measure the feasibility of successful enrollment.
Number of Patients Recruited Per Month
时间窗: Assessed at 10 Month from the beginning of enrollment
This is designed to measure the rate of enrollment, with \<4 patients/month considered not meeting outcome
Proportion of Participants Who Complete the 4-weeks Assessments
时间窗: 4 weeks post-enrollment
This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.
Horner's Syndrome
时间窗: Immediately post-procedure
Horner syndrome is a condition that affects the face and eye on one side of the body, being caused by a disrupted nerve pathway from the brain to the head and neck. This syndrome can be assessed through a visual exam, involving the observation of decreased pupil size, a drooping eyelid and decreased sweating on the affected side of the face.
The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation
时间窗: Assessed at baseline post-procedure
This is designed to assess the feasibility of administering psychoeducation, with \>80% of the components in the checklist as a threshold for success.
Total Actigraph Wear Time
时间窗: Assessed at 4-weeks post-procedure
the proportion of participants with \>80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy
次要结局
- The Proportion of Participants With Moderate to High Levels of Physical Activity.(Assessed at 4-weeks post-discharge)
- The Proportion of Participants With Clinically Significant Symptoms of Depression.(Assessed pre-procedure and then repeated at 4-weeks post-procedure)
- The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety(Assessed pre-procedure and then repeated at 4-weeks post-procedure)
- The Proportion of Participants With Reduced Duration of Sleep.(Assessed at 4-weeks post-discharge)
- The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.(Assessed pre-procedure and then repeated at 4-weeks post-procedure)
- Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)(Assessed pre-procedure and then repeated at 4-weeks post-procedure)
研究者
Sachin Agarwal
Assistant Professor of Neurology, Department of Neurology
Columbia University