Same Day Subcutaneous ICD And Send Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Rate of Successful Completion of S-ICD Implantation and Discharge of the Patient on the Same Day the Device is Implanted Using the Analgesia Protocol.
研究概览
简要总结
Design: Prospective, non-randomized single center study at The Ohio State University Wexner Medical Center.
Purpose: The purpose of this study is to prospectively evaluate a specific analgesia protocol designed to allow for same day discharge following implantation of the subcutaneous implantable cardiac defibrillator (S-ICD) Enrollment: Up to 40 subjects will be enrolled. Subject Population: Consecutive patients undergoing S-ICD implantation under general anesthesia or monitored anesthesia care.
Endpoints: Rate of successful completion of the protocol; Procedural complications; Serial assessment of patient perception of pain.
详细描述
This is a prospective, nonrandomized, descriptive, single center study designed to assess the rate of successful completion of the study protocol in consecutive patients undergoing S-ICD implantation.
Objectives To prospectively evaluate the same day discharge protocol for patients undergoing S-ICD implantation.
Primary Endpoint 1. Rate of successful completion of S-ICD implantation and discharge of the patient on the same day the device is implanted using the analgesia protocol.
Secondary Endpoints
- Procedure complication (failed implantation, infection, hematoma/bleeding, etc...) within 30 days of procedure.
- Serial assessment of patient perception of pain using the graded integer pain scale of 1-10
- Side effects related to medical therapy of protocol.
- Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit.
- 30 day readmission rate after discharge following S-ICD implant
- Number of days that oral analgesics are used post discharge.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consented for implantation of S-ICD.
- •Ambulatory/outpatient patient coming to the hospital setting solely for implantation of S-ICD
- •Patient agrees to participate and is able to comply with the defined study protocol, including assistance for home care and transportation for the first ≈12-18 hours post discharge, and compliance with the required follow up.
排除标准
- •Inability or unwillingness to provide informed consent
- •Patients who, for any reason, was hospitalized or in an emergency department the day prior to the S-ICD implantation, including patients transferred for S-ICD implantation
- •Patients in which the hemodynamics are dependent upon intravenous pressors infusing at the time of device implantation or mechanical support, inclusive of left ventricular assist device and intravenous devices (balloon pump, Impella device).
- •Age < 18 years.
- •Pregnancy.
- •Currently incarcerated.
- •Hypoxia (room air oxygen <91%) or acutely short of breath.
- •Hypotension (Systolic blood pressure <90) unless this is patient's typical blood pressure).
- •Bradycardia (heart rate <45bpm, unless this is patient's typical resting heart rate).
- •Acute electrolyte disorder that cannot be easily corrected (e.g., potassium supplementations) based upon Chem 6 values obtained on day of procedure.
- •Presence of a fever.
研究组 & 干预措施
Intervention
S-ICD implantation.
干预措施: Subcutaneous ICD with same day discharge (Device)
结局指标
主要结局
Rate of Successful Completion of S-ICD Implantation and Discharge of the Patient on the Same Day the Device is Implanted Using the Analgesia Protocol.
时间窗: within 30 days of the procedure
Rate of successful completion of S-ICD implantation and discharge of the patient on the same day the device is implanted using the analgesia protocol.
次要结局
- Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.(within 30 days of the procedure)
- Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10(within 30 days of the procedure)
- Side Effects Related to Medical Therapy of Protocol.(within 30 days of the procedure)
- Time From Beginning of Recovery (Defined as When the Patient Enters the Recovery IPR Room) to the Time of Discharge From the Recovery Unit.(within 30 days of the procedure)
- 30 Day Readmission Rate After Discharge Following S-ICD Implant(within 30 days of the procedure)
- Number of Days That Oral Analgesics Are Used Post Discharge.(within 30 days of the procedure)
研究者
Emile Daoud, MD
Sub-Investigator
Ohio State University