Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention arm Clear fluids and food up to up to 1 hour before the procedure |
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
|
| No Intervention: Control arm Fasting for solids for up to 6 hours and fluids up to 2 hours before the procedure |
Outcome Measures
Primary Outcome Measures
- 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
- Usages of inotropic and vasopressor agents [During the intervention]
Amount of used inotropic and vasopressor agents during the intervention
- Usage of sedatives [During the intervention]
Amount of used sedative agents during the intervention
- 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
- Serum creatinine level [1 hour pre-procedural, during the first 24 hours after the procedure]
Serum creatinine (mg/dL)
- Serum urea level [1 hour pre-procedural, during the first 24 hours after the procedure]
Serum urea (mg/dL)
- 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.
- 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
- Oxygen saturation [pre-intervention, and then every 15 minutes during the procedure]
Oxygen saturation (%) will be assessed by using a monitoring device
- 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 pH [1 hour pre-procedural]
Will be assessed by venous blood gas analysis (number).
- blood PaCo2 [1 hour pre-procedural]
Will be assessed by venous blood gas analysis (mmHg).
- blood HCO3 [1 hour pre-procedural]
Will be assessed by venous blood gas analysis (mEq/L).
- 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.
- Potassium [1 hour pre-procedural, pre-intervention, 8 hours after procedure]
Will be assessed by blood test (mm/L).
- 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)
- 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)
- 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)
- 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
- Operation site infection rate [During 30 days after the procedure]
Operation site (Chest) infection rate via Telephone /follow-up visits
- 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
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Electrophysiology, Leipzig Heart Center | Leipzig | Saxony | Germany | 04289 |
Sponsors and Collaborators
- Leipzig Heart Institute GmbH
Investigators
- Principal Investigator: Kerstin Bode, MD, MSc, Heart Center Leipzig at the University of Leipzig
- Principal Investigator: Alireza Sepehri Shamloo, MD, Heart Center Leipzig at the University of Leipzig
- Study Chair: Gerhard Hindricks, MD, Heart Center Leipzig at the University of Leipzig
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-0310