NPO and Patient Satisfaction in the Cath Lab

Stony Brook University200 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Patient Satisfaction Dehydration Physiological Effects Secondary to Dehydration

Interventions

NPO past midnightOTHER

NPO after midnight (solids and liquids), except for a sip of water with medication.

NPOOTHER

No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to 24 hours

Secondary Outcomes

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

Time frame: Through the end of hospitalization, usually 2 days.

Central Contacts

Derek Atkinson, MD

CONTACT

631-748-9310 derek.atkinson@stonybrookmedicine.edu

Data from ClinicalTrials.gov

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