NPO and Patient Satisfaction in the Cath Lab

NCT ID: NCT04079543

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2021-09-09

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.

Conditions

Patient Satisfaction; Dehydration; Physiological Effects Secondary to Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Strict NPO

NPO after midnight. No solids or liquids after midnight.

Group Type: OTHER

NPO past midnight

Intervention Type: OTHER

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

Liberal NPO

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

Group Type: OTHER

NPO

Intervention Type: OTHER

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

Interventions

NPO past midnight

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

Intervention Type: OTHER

NPO

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Derek Atkinson

Cardiac Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Derek Atkinson, MD

Role: CONTACT

derek.atkinson@stonybrookmedicine.edu

631-748-9310

References

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.

Reference Type: DERIVED

PMID: 37553699 (View on PubMed)

Other Identifiers

IRB2019-00261

Identifier Type: -

Identifier Source: org_study_id