NPO and Patient Satisfaction in the Cath Lab

Patient Satisfaction Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04079543
• Other study ID #: IRB2019-00261
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: September 9, 2021

Study information

• Verified date: September 2019
• Source: Stony Brook University
• Contact: Derek Atkinson, MD
• Phone: 631-748-9310
• Email: derek.atkinson[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Patient Satisfaction
• Physiological Effects Secondary to Dehydration

Intervention

Other:
• NPO past midnight
NPO after midnight (solids and liquids), except for a sip of water with medication.
• NPO
No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.