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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strict NPO | Other | NPO after midnight. No solids or liquids after midnight. |
|
| Liberal NPO | Other | No solids after midnight. Clear liquids up to 2 hours prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPO past midnight | Other | NPO after midnight (solids and liquids), except for a sip of water with medication. |
|
| 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 |
| 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.
| Through the end of hospitalization, usually 2 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek Atkinson, MD | Contact | 631-748-9310 | derek.atkinson@stonybrookmedicine.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37553699 | Derived | Atkinson DJ, Romeiser JL, Almasry IO, Tannous HJ, Parikh PB, Bennett-Guerrero E. Randomized controlled trial of liberal vs. standard fasting instructions in percutaneous cardiac procedures. Perioper Med (Lond). 2023 Aug 8;12(1):44. doi: 10.1186/s13741-023-00333-z. |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D014883 | Water-Electrolyte Imbalance |
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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).
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| NPO | Other | No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water. |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |