Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)

Helios Health Institute GmbH

Status

Completed

Conditions

Cardiac Implantable Electronic Devices

Treatments

Dietary Supplement: Clear fluids and food up to up to 1 hour before the procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT04389697

2019-0310

Details and patient eligibility

About

There was no evidence to suggest that a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. However, there is no available data regarding the safety and efficacy of fasting approach in patients undergoing cardiac implantable electronic device (CIED) procedures. The aim of this study is to demonstrate that a non-fasting protocol is non-inferior in regard to safety to a fasting protocol (current practice) in patients undergoing cardiac device implantation procedures

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients >18 years undergoing elective implantation or generator exchange of cardiac implantable electronic devices

Exclusion criteria

Patients presenting with an acute unstable condition (bradycardia < 30/min or temporary pacing wire)
Patients scheduled for deep sedation
Patients with increased intra-abdominal pressure (severe intra-abdominal tumors, severe ascites, very severe obesity: BMI>40 kg/m2).