Status:

COMPLETED

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

Lead Sponsor:

Helios Health Institute GmbH

Conditions:

Cardiac Implantable Electronic Devices

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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' fast...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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).

Key Trial Info

Start Date :

January 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 6 2020

Estimated Enrollment :

201 Patients enrolled

Trial Details

Trial ID

NCT04389697

Start Date

January 29 2020

End Date

December 6 2020

Last Update

March 17 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Electrophysiology, Leipzig Heart Center

Leipzig, Saxony, Germany, 04289

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