NPO and Patient Satisfaction in the Cath Lab

NCT04079543 | Unknown

• 1 other identifier: IRB2019-00261
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Satisfaction; Dehydration; Physiological Effects Secondary to Dehydration

Keywords

Nil per os (NPO); TAVR; arrhythmia ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exploratory Analyses

  Through the end of hospitalization, usually 2 days.

Study Arms (2)

Strict NPO

OTHER

NPO after midnight. No solids or liquids after midnight.

Other: NPO past midnight

Liberal NPO

OTHER

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

Other: NPO

Interventions

NPO past midnight OTHER

NPO after midnight (solids and liquids), except for a sip of water with medication.

Strict NPO

NPO OTHER

No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.

Liberal NPO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Related Publications (1)

• 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.

  PMID: 37553699 DERIVED

MeSH Terms

Conditions

Patient Satisfaction; Dehydration

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Derek Atkinson, MD

CONTACT

631-748-9310; derek.atkinson@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Model Details: 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).

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: September 9, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09