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

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Leipzig Heart Institute GmbH
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Updated on 16 February 2024
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Summary

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

Details
Condition Cardiac Implantable Electronic Devices
Age 18years - 100years
Treatment Clear fluids and food up to up to 1 hour before the procedure
Clinical Study IdentifierNCT04389697
SponsorLeipzig Heart Institute GmbH
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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)
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