Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Success of Using Regional Anesthesia for Impella 5.5 Placement
研究概览
简要总结
The Abiomed Impella 5.5 is a surgically placed temporary mechanical support device used in patients in cardiogenic shock. The investigators propose using regional anesthesia (3 separate peripheral nerve blocks) to facilitate Impella 5.5 placement, a procedure which has traditionally been performed under a general anesthetic.
Regional anesthesia is a proven and widely used technique to facilitate upper extremity vascular surgery cases (i.e. arteriovenous fistula creation). The investigators believe that employing these blocks in conjunction with intravenous sedation or monitored anesthesia care (MAC anesthesia) - a technique used in all types of cases, even in sick hearts during thranscatheter aortic valve replacements (TAVR) - will avoid the need increased doses of medications to support the blood pressure and cardiac output, avoid the need for post operative mechanical ventilation and intravenous sedation, and speed up the time to participating in physical therapy, time to heart transplant/durable mechanical support/recovery, and time to hospital discharge.
详细描述
General anesthesia places patients who are in cardiogenic shock at risk for life threatening hemodynamic compromise due to the anesthetic and positive pressure ventilation, and confers the need for mechanical ventilation and sedation post operatively.
Our hypothesis is that by utilizing regional anesthesia, anesthesiologists can facilitate surgical Impella placement with less risk of cardiovascular collapse with a faster road to recovery. By avoiding endotracheal intubation and concomitant heavy sedation both in the operating room and ICU, these patients will avoid worsening deconditioning and ICU delirium, with less days to physical therapy, ambulation, and recovery as compared to patients who undergo general anesthesia and remain ventilated in the ICU after their Impella placement.
Patients scheduled for Impella 5.5 placement will be screened by a specific set of inclusion/exclusion criteria for potential participation in the study. If they consent, they will receive three commonly used upper extremity nerve blocks (Interscalene, PECS II, and superficial cervical plexus nerve blocks) and receive only intravenous sedation during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No blinding in this study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline Criteria:
- •Agrees to procedure
- •Excellent ultrasound images for nerve blocks
- •Excellent ultrasound images for trans thoracic echo
- •Age <60, BMI <30
- •Non hostile neck
- •Evaluation of CT amenable to easy surgical access for Impella placement
- •Meets criteria for MAC sedation:
- •Able to lay relatively flat comfortably
- •Able to understand and cooperate with procedures
- •Easy airway (Mallampati I - II, prior grade 1-2 airway)
- •Low risk of airway obstruction
- •No high baseline oxygen requirement (over 6L/min)
- •Meets criteria for regional anesthesia:
- •Patient agrees to nerve block
- •No active areas of infection around the block site
- •No history of nerve damage or deficits in the area of the proposed nerve block
- •No contralateral diaphragmatic paralysis or phrenic nerve palsy
排除标准
- •Does not wish to have MAC
- •Does not wish to have Regional Anesthesia
- •BMI > 30
- •Poor U/S windows for block or TTE
- •Active infection over block area
- •High Oxygen Requirement >6L NC
- •Known or anticipated difficult airway
- •Unable to lay flat comfortably Unable to cooperate or follow instructions
结局指标
主要结局
Success of Using Regional Anesthesia for Impella 5.5 Placement
时间窗: Day of procedure (1 day)
Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol
次要结局
- Patient pain scores post operatively(3 days)
- Time to participation in physical therapy(6 weeks)
- Time to destination therapy(6 weeks)
- Pain medication requirement(1 week)
- Sedation requirement(1 week)