Dehydration, Patient Satisfaction, Physiological Effects Secondary to Dehydration
Conditions
Keywords
Nil per os (NPO), TAVR, arrhythmia ablation
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.
Interventions
OTHERNPO past midnight
NPO after midnight (solids and liquids), except for a sip of water with medication.
OTHERNPO
No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactDerek Atkinson, MD
Outcome results
None listed