Evaluation of an Enhanced Recovery Pathway for Endoscopy Patients Receiving Moderate Sedation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period.
研究概览
简要总结
The purpose of this study is to compare an Enhanced Recovery Pathway to the current pre-operative/recovery practices of the endoscopy department on patient post-procedure outcomes.
详细描述
Every 4th to 5th patient that checks in to the endoscopy department for their procedure will be screened for eligibility requirements. If eligible for the study, the patient will be informed about the study and potential risks. All patients giving written informed consent will be enrolled into the enhanced recovery protocol (ERP) [nursing managed ERP: goal-directed fluid management (Lactated Ringer's Solution at 5mL/kg/hr), PONV prophylaxis for an apfel score of 2 or greater (ondansetron 4 mg IV), early mobilization up to chair (within 5-30 minutes of admission to the recovery room), and early PO intake within 15-30 minutes of admission to the recovery room post-procedure] for their procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Outpatient colonoscopy under moderate sedation
- •Colonoscopy Indications: Screening
排除标准
- •More than one sedation procedure scheduled same day
- •Allergy to ondansetron
- •Past PONV requiring scopolamine patches
- •Diagnoses: ESRD, heart failure, cirrhosis, long QT syndrome
- •Patients requiring fluid restrictions, such as dialysis patients
- •Post-procedure NPO requirements, such as procedure-related NPO status (stent placement, pneumatic dilation, etc.) or second procedure in another location
- •High Fall Risk Patients
- •Adults unable to consent
- •Pregnant patients
研究组 & 干预措施
Prospective Experimental Group
For the experimental group, we will recruit 200 participants who will receive the Enhanced Recovery Pathway, which will be ordered as a standing order set by the attending provider and managed by their peri-procedural nurses. The modified ERP for this study includes the following interventions: nursing managed order sets with ERP instructions to receive goal-directed fluid management within anesthesia approved parameters utilizing the NMH Colorectal ERAS protocol for IV fluid administration, PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis, early mobilization up to chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters, and early PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters.
干预措施: Ondansetron 4 MG (Drug)
Prospective Experimental Group
For the experimental group, we will recruit 200 participants who will receive the Enhanced Recovery Pathway, which will be ordered as a standing order set by the attending provider and managed by their peri-procedural nurses. The modified ERP for this study includes the following interventions: nursing managed order sets with ERP instructions to receive goal-directed fluid management within anesthesia approved parameters utilizing the NMH Colorectal ERAS protocol for IV fluid administration, PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis, early mobilization up to chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters, and early PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters.
干预措施: Lactated Ringers, Intravenous (Drug)
Prospective Experimental Group
For the experimental group, we will recruit 200 participants who will receive the Enhanced Recovery Pathway, which will be ordered as a standing order set by the attending provider and managed by their peri-procedural nurses. The modified ERP for this study includes the following interventions: nursing managed order sets with ERP instructions to receive goal-directed fluid management within anesthesia approved parameters utilizing the NMH Colorectal ERAS protocol for IV fluid administration, PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis, early mobilization up to chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters, and early PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters.
干预措施: Early Mobilization (Other)
Prospective Experimental Group
For the experimental group, we will recruit 200 participants who will receive the Enhanced Recovery Pathway, which will be ordered as a standing order set by the attending provider and managed by their peri-procedural nurses. The modified ERP for this study includes the following interventions: nursing managed order sets with ERP instructions to receive goal-directed fluid management within anesthesia approved parameters utilizing the NMH Colorectal ERAS protocol for IV fluid administration, PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis, early mobilization up to chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters, and early PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters.
干预措施: Early PO Intake (Other)
结局指标
主要结局
To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period.
时间窗: 1-2 hours
We will compare mean recovery times between control and intervention groups using analysis of variance (ANOVA).
To compare the incidence of postoperative nausea and vomiting before and after implementing a modified ERAs for endoscopy patients in the recovery period.
时间窗: 1-2 hours
We will perform a Chi-square analysis for presence or absence of nausea and/or vomiting in the recovery period (measured by: administration of anti-emetic, documentation on N/V flowchart, and/or documentation in nursing narrative note) between control and intervention groups.
次要结局
- To compare patient satisfaction scores before and after implementing a modified ERAs for endoscopy patients in the recovery period.(15 minutes)
研究者
Angela Maeder
PhD, RNC-OB, Clinical Nurse, Labor and Delivery Northwestern Memorial Hospital
Northwestern University