NPO and Patient Satisfaction in the Cath Lab (FAST)

Stony Brook University

Status: Unknown

Conditions: Dehydration; Patient Satisfaction; Physiological Effects Secondary to Dehydration

Treatments: Other: NPO; Other: NPO past midnight

Study type: Interventional

Funder types: Other

Identifiers

NCT04079543

IRB2019-00261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Strict NPO

Other group

Description:

NPO after midnight. No solids or liquids after midnight.

Treatment:

Other: NPO past midnight

Liberal NPO

Other group

Description:

No solids after midnight. Clear liquids up to 2 hours prior to surgery.

Treatment:

Other: NPO