Enhanced Recovery Pathway for Endoscopy

Phase 4

Withdrawn

• Conditions: Enhanced Recovery Pathway; Endoscopy
• Interventions: Drug: Ondansetron 4 MG; Drug: Lactated Ringers, Intravenous; Other: Early Mobilization; Other: Early PO Intake

• Registration Number: NCT04983498
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-30
• Study Start: 2021-09-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Primary Completion: 2021-12-01
• Last Update Posted: 2021-12-15
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Outpatient colonoscopy under moderate sedation
• Colonoscopy Indications: Screening

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Prospective Experimental Group	Ondansetron 4 MG	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.
Prospective Experimental Group	Lactated Ringers, Intravenous	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.
Prospective Experimental Group	Early Mobilization	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.
Prospective Experimental Group	Early PO Intake	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.

Primary Outcome Measures

Name	Time	Method
To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period.	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.	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.

Secondary Outcome Measures

Name	Time	Method
To compare patient satisfaction scores before and after implementing a modified ERAs for endoscopy patients in the recovery period.	15 minutes	We will perform a t-test of patient satisfaction scores (Press Ganey scores) between control and intervention groups.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States