Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization (CALORI (NPO))

A Randomized Trial of Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization

Moderate sedation is used in the catheterization laboratory relieve the anxiety and discomfort associated with access and other aspects of the procedure. Whether being in a fasting state (nothing per os, NPO) at the time of the procedure is beneficial or harmful is not well known, but patients are typically required to be fasting at the time of elective procedures, guidance derived from procedures that require general anesthesia. Whereas the typical thinking was that fasting prior to procedures would minimize the risk of aspiration in the event of intubation, or nausea and other symptoms generally, several studies have shown that prolonged fasting prior to procedures is associated with increased nausea, vomiting, aspiration and procedure recovery time.

We aim to evaluate patient satisfaction, nausea and immediate outcomes of patients who are not kept NPO prior to cardiac catheterization.

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Procedure: Coronary angiogram; Procedure: Right heart catheterization

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >18 years of age
• Requiring a cardiac catheterization as per standard of care
• Elective procedure with planned moderate sedation

Exclusion Criteria:

• BMI >45
• All emergent procedures
• All mechanical circulatory support-assisted procedures
• Other high risk procedures (as identified by the operator)
• Pregnant women
• Hemodynamically unstable patients
• Active GI illness, including nausea at the time of screening
• Taking chronic pain medications at home or on current brief course of narcotics
• Dementia
• Encephalopathy
• Patients scheduled for deep sedation
• Severe GERD (if the patient requires more than one medication for adequate control of GERD symptoms or has required medical intervention within the past year)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fasting group; Participant will be asked to fast at least 6 hours prior to the procedure	Procedure: Coronary angiogram; Being done per standard of care; Procedure: Right heart catheterization; Being done per standard of care
Experimental: Non-Fasting group; Participants will be allowed to eat and drink up to 1 hour prior to the procedure.	Procedure: Coronary angiogram; Being done per standard of care; Procedure: Right heart catheterization; Being done per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)	We get a wellness score prior to the procedure (right before the patient is taken into the lab) and is on a 0-5 scale with 0 being very happy and 5 being very unhappy.	Baseline (Prior to procedure)
Intra- and post-procedural vomiting, aspiration, and intubation checklist	We review the chart and ask the participant if they had any vomiting. We also review the chart to see if there are any reports/concern of aspiration and follow up on any chest X-rays that were obtained.	Within 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Zachary Gertz, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: HM20025962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing will be considered upon each individual request.
• IPD Sharing Time Frame: Data sharing will be considered upon each individual request.
• IPD Sharing Access Criteria: Data sharing will be considered upon each individual request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No