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

Primary Purpose

Heart Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coronary angiogram
Right heart catheterization
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fasting group

Non-Fasting group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
May 9, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05851872
Brief Title
Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization
Acronym
CALORI (NPO)
Official Title
A Randomized Trial of Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting group
Arm Type
Active Comparator
Arm Description
Participant will be asked to fast at least 6 hours prior to the procedure
Arm Title
Non-Fasting group
Arm Type
Experimental
Arm Description
Participants will be allowed to eat and drink up to 1 hour prior to the procedure.
Intervention Type
Procedure
Intervention Name(s)
Coronary angiogram
Intervention Description
Being done per standard of care
Intervention Type
Procedure
Intervention Name(s)
Right heart catheterization
Intervention Description
Being done per standard of care
Primary Outcome Measure Information:
Title
Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)
Description
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.
Time Frame
Baseline (Prior to procedure)
Title
Intra- and post-procedural vomiting, aspiration, and intubation checklist
Description
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.
Time Frame
Within 24 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary Gertz, MD
Phone
804-828-1601
Email
zachary.gertz@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Gertz, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Gertz, MD
Email
zachary.gertz@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Anna Tomdio
Email
anna.tomdio@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Zachary Gertz, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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