NCT04079543

NPO and Patient Satisfaction in the Cath Lab

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patient Satisfaction
• Dehydration
• Physiological Effects Secondary to Dehydration

Interventions

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

Timeline

• Start date: 2019-09-09
• Primary completion: 2020-09-09
• Completion: 2021-09-09
• First posted: 2019-09-06
• Last updated: 2019-09-06