Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization

Heart Diseases Clinical Trial

— CALORI (NPO)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05851872
• Other study ID #: HM20025962
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Procedure:
• Coronary angiogram
Being done per standard of care
• Right heart catheterization
Being done per standard of care

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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