CClinicalTrials.gg
CompletedNCT05851872CALORI (NPO)Updated May 16, 2024

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

An interventional study of Coronary angiogram and Right heart catheterization in Heart Diseases, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
169
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Heart Diseases

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03

In context

Heart Diseases

3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 169 is above the median of 100 across 1,779 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
169 participants (actual)

Study arms

  • Active comparator
    Fasting group

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

    Procedure: Coronary angiogram · Procedure: Right heart catheterization

  • Experimental
    Non-Fasting group

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

    Procedure: Coronary angiogram · Procedure: Right heart catheterization

Interventions

  • ProcedureCoronary angiogram

    Being done per standard of care

  • ProcedureRight heart catheterization

    Being done per standard of care

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Prior to procedure)

  2. 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.

    Time frame: Within 24 hours after the procedure

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Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23284, United States
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References and documents

Individual participant data

Plan to share: Yes — Data sharing will be considered upon each individual request.

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05851872
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
May 10, 2023
Start date
Mar 1, 2023
Primary completion
Dec 5, 2023
Completion
Dec 5, 2023
Last update
May 16, 2024

Study contacts

Zachary Gertz, MD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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