NCT05851872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 1, 2023

Last Update Submit

May 13, 2024

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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

Study Arms (2)

Fasting group

ACTIVE COMPARATOR

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

Procedure: Coronary angiogramProcedure: Right heart catheterization

Non-Fasting group

EXPERIMENTAL

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

Procedure: Coronary angiogramProcedure: Right heart catheterization

Interventions

Coronary angiogramPROCEDURE

Being done per standard of care

Fasting groupNon-Fasting group
Right heart catheterizationPROCEDURE

Being done per standard of care

Fasting groupNon-Fasting group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Zachary Gertz, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

March 1, 2023

Primary Completion

December 5, 2023

Study Completion

December 5, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Data sharing will be considered upon each individual request.

Shared Documents
STUDY PROTOCOL
Time Frame
Data sharing will be considered upon each individual request.
Access Criteria
Data sharing will be considered upon each individual request.

Locations

US(1)