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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05851872

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

44.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases	Procedure: Coronary angiogram Procedure: Right heart catheterization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pre-procedure wellness score (hunger, tiredness, anxiety, nausea) [Baseline (Prior to procedure)]
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.
Intra- and post-procedural vomiting, aspiration, and intubation checklist [Within 24 hours after the procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23284

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator: Zachary Gertz, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT05851872

Other Study ID Numbers:

HM20025962

First Posted:

May 10, 2023

Last Update Posted:

May 10, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of May 10, 2023