NPO and Patient Satisfaction in the Cath Lab

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patient Satisfaction, Dehydration, Physiological Effects Secondary to Dehydration

Intervention / Treatment
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* Other: NPO past midnight
* Other: NPO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized (1:1) into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure).
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nil per os (NPO), TAVR, arrhythmia ablation