NCT04389697

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Helios Health Institute GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiac Implantable Electronic Devices

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Clear fluids and food up to up to 1 hour before the procedure	Clear fluids and food up to up to 1 hour before the start of the procedure

Timeline

• Start date: 2020-01-29
• Primary completion: 2020-11-06
• Completion: 2020-12-06
• First posted: 2020-05-15
• Last updated: 2021-03-17

Locations

1 site across 1 country: Germany