NPO and Patient Satisfaction in the Cath Lab (FAST)

Randomized Controlled Trial of Liberalized NPO Status to Improve Patient Satisfaction in Patients Undergoing Procedures in the Cardiac Catheterization Lab

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.

Study Overview

• Status: Unknown
• Conditions: Dehydration; Patient Satisfaction; Physiological Effects Secondary to Dehydration
• Intervention / Treatment: Other: NPO past midnight; Other: NPO

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Strict NPO; NPO after midnight. No solids or liquids after midnight.	Other: NPO past midnight; NPO after midnight (solids and liquids), except for a sip of water with medication.
Other: Liberal NPO; No solids after midnight. Clear liquids up to 2 hours prior to surgery.	Other: NPO; No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction: survey	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.	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Analyses	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	Through the end of hospitalization, usually 2 days.

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 9, 2019
• Primary Completion (Anticipated): September 9, 2020
• Study Completion (Anticipated): September 9, 2021

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: TAVR; Nil per os (NPO); arrhythmia ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: IRB2019-00261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No