NPO and Patient Satisfaction in the Cath Lab

Not Applicable

• Conditions: Patient Satisfaction; Dehydration; Physiological Effects Secondary to Dehydration

• Registration Number: NCT04079543
• Lead Sponsor: Stony Brook University

Brief Summary

The purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.

Detailed Description

After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Study Start: 2019-09-09
• Primary Completion: 2020-09-09
• Study Completion: 2021-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years of age or older,
• patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
• ability to provide written informed consent

Exclusion Criteria

• Age less than 18 years
• emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
• patients not alert and oriented to person, place, and date,
• concurrent surgical procedures on the day of TAVR or arrhythmia ablation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction: survey	Up to 24 hours	The primary objective is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction. Patient satisfaction will be determined by a patient satisfaction survey given 2 hours (+/- 2 hrs) prior to procedure. This survey will assess: thirst, hunger, headache, nausea, lightheadedness, and anxiety.

Secondary Outcome Measures

Name	Time	Method
Exploratory Analyses	Through the end of hospitalization, usually 2 days.	An independent analysis of each individual component of the satisfaction survey will be performed. Each variable will be scored on a scale of 0-10. Variables: thirst, hunger, headache, nausea, lightheadedness, anxiety.; * Renal Function; * Vasopressor Requirement; * Post-operative nausea and vomiting; * Post-operative hospital length of stay