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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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

Eligibility

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).

Study details
    Cardiac Implantable Electronic Devices

NCT04389697

Leipzig Heart Institute GmbH

16 February 2024

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