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

N/ANot Yet RecruitingNCT07150780

Munson Medical Center2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

2,000

Conditions

Coronary Artery Disease Cardiac Catheterization Cardiac Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Adults unable to consent * Pregnant women * Incarceration * Non-English-speaking patients * Inability to eat by mouth * Patients requiring general anesthesia for cardiac catheterization * Inability to fast for at least 6 hours * Personal history of pulmonary aspiration, or other known cardiopulmonary anesthetic complication(s) * Urgent cardiac catheterization * Inability or unwillingness to comply with all study procedures * Previously enrolled in this study (patients may not be enrolled more than once for subsequent procedures)

Outcomes

Primary Outcomes

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.

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.