Benefits of no Fasting Compared to Fasting Prior to Elective Cardiac Catheterization: A Single-center Randomized-controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMunson Medical Center

About this trial

More than one million cardiac catheterizations (CCs) are performed annually in the United States and the majority are elective. Current guidelines recommend no fasting prior to elective CC, however recent studies suggest that eating and drinking as desired prior to elective CCs involving moderate sedation is safe.

This project will study the potential benefits of allowing patients to eat before elective CCs. Participants will be randomly divided into two groups. One group will receive pre-op instructions to fast, and the other group will be allowed to eat and drink as desired prior to their CC. Researchers will compare these groups with regards to patient satisfaction and respiratory complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to comply with all study procedures and remain in contact with the study team to complete study assessments for the duration of the study

Scheduled for an elective (non-urgent) cardiac catheterization

Age of 18 or older at the time of consent

Disqualifiers

Adults unable to consent

Pregnant women

Incarceration

Non-English-speaking patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pre-operative instructions to eat and drink at liberty

    Procedure/Surgery

    Subjects will be instructed to eat and drink at liberty prior to their schedule elective cardiac catheterization.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: FastingNo intervention 0 interventions
Group B: Non-fastingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Satisfaction

Six-point ordinal scale response preoperative fasting questionnaire. Self-reported.

Time frame
Immediate pre-procedure period, not more than four hours before procedure start-time.
2

Pulmonary aspiration/pneumonitis/pneumonia

Indicated by an acute change in oxygen requirement noted in the procedure note or post-procedure progress note. Assessed by chart review. Present/absent.

Time frame
From procedure start time to 48 hours post-procedure.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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