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

Not Applicable

Completed

• Conditions: Cardiac Implantable Electronic Devices
• Interventions: Dietary Supplement: Clear fluids and food up to up to 1 hour before the procedure

• Registration Number: NCT04389697
• Lead Sponsor: Helios Health Institute GmbH

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' 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study Start: 2020-01-29
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-15
• Primary Completion: 2020-11-06
• Study Completion: 2020-12-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	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 procedure

Primary Outcome Measures

Name	Time	Method
Patients well-being	During the first 24 hours after the procedure	Post-interventional patients well-being including (to be assessed by questionnaire with the help of a Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome): abdominal pain, thirst, mouth dryness, headache, anxiety, hunger, nausea, vomiting, tiredness and weakness, dizziness Incidence of Intra -procedural adverse events like emergency intubation and perioperative pulmonary aspiration vomiting)

Secondary Outcome Measures

Name	Time	Method
blood PaCo2	1 hour pre-procedural	Will be assessed by venous blood gas analysis (mmHg).
Surgical site pain	During the first 24 hours after the procedure	Surgical site pain based on Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome)
Patients general satisfaction	During the first 24 hours after the procedure	Patients general satisfaction with procedure as assessed by the patient satisfaction survey form using Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)
Serum urea level	1 hour pre-procedural, during the first 24 hours after the procedure	Serum urea (mg/dL)
Serum creatinine level	1 hour pre-procedural, during the first 24 hours after the procedure	Serum creatinine (mg/dL)
Oxygen saturation	pre-intervention, and then every 15 minutes during the procedure	Oxygen saturation (%) will be assessed by using a monitoring device
blood pH	1 hour pre-procedural	Will be assessed by venous blood gas analysis (number).
Length of ICU stay	Up to 30 days	Based on the number of ICU stay nights
Length of hospital stay	Up to 30 days	Based on the number of ICU stay nights plus ward stay
Usage of sedatives	During the intervention	Amount of used sedative agents during the intervention
eGFR	1 hour pre-procedural, during the first 24 hours after the procedure	GFR is Glomerular Filtration Rate and it is a key indicator of renal function. eGFR is estimated GFR and is a mathematically derived entity based on a patient's serum creatinine level, age, sex and race.
Blood pressure	pre-intervention, and then every 15 minutes during the procedure	Systolic and diastolic blood pressure (mmHg) will be assessed by using a monitoring device
blood sugar	1 hour pre-procedural, pre-intervention, 8 hours after procedure	Will be assessed by venous blood gas analysis (mg/dL).
Sodium	1 hour pre-procedural, pre-intervention, 8 hours after procedure	Will be assessed by blood test.
Usage of analgesics	During the intervention	Amount of used analgesics agents during the intervention
Usage anti-vomiting agents	During the intervention	Amount of used anti-vomiting agents during the intervention
Usages of inotropic and vasopressor agents	During the intervention	Amount of used inotropic and vasopressor agents during the intervention
Heart rate	pre-intervention, and then every 15 minutes during the procedure	Heart rate (frequency per minute) will be assessed by using a monitoring device
blood HCO3	1 hour pre-procedural	Will be assessed by venous blood gas analysis (mEq/L).
Potassium	1 hour pre-procedural, pre-intervention, 8 hours after procedure	Will be assessed by blood test (mm/L).
Incidence of death	During 30 days after the procedure	The investigators will then divide the causes into 1) operation related and 2) non-operation related causes
Sleep quality	During the first 24 hours after the procedure	Sleep quality based on Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)
Operation site infection rate	During 30 days after the procedure	Operation site (Chest) infection rate via Telephone /follow-up visits

Trial Locations

Locations (1)

Department of Electrophysiology, Leipzig Heart Center; 🇩🇪 Leipzig, Saxony, Germany