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

NCT ID: NCT05851872

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-12-05

Brief 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.

Conditions

Heart Diseases

Study Design

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

Study Groups

Fasting group

Participant will be asked to fast at least 6 hours prior to the procedure

Group Type: ACTIVE_COMPARATOR

Coronary angiogram

Intervention Type: PROCEDURE

Being done per standard of care

Right heart catheterization

Intervention Type: PROCEDURE

Being done per standard of care

Non-Fasting group

Participants will be allowed to eat and drink up to 1 hour prior to the procedure.

Group Type: EXPERIMENTAL

Coronary angiogram

Intervention Type: PROCEDURE

Being done per standard of care

Right heart catheterization

Intervention Type: PROCEDURE

Being done per standard of care

Interventions

Coronary angiogram

Being done per standard of care

Intervention Type: PROCEDURE

Right heart catheterization

Being done per standard of care

Intervention Type: PROCEDURE

Eligibility Criteria

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)

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

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zachary Gertz, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20025962

Identifier Type: -

Identifier Source: org_study_id