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

Cardiac Implantable Electronic Devices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389697
• Other study ID #: 2019-0310
• Status: Completed
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: December 6, 2020

Study information

• Verified date: March 2021
• Source: Leipzig Heart Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Devices

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Electrophysiology, Leipzig Heart Center	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Leipzig Heart Institute GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients well-being	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)	During the first 24 hours after the procedure
Secondary	Usages of inotropic and vasopressor agents	Amount of used inotropic and vasopressor agents during the intervention	During the intervention
Secondary	Usage of sedatives	Amount of used sedative agents during the intervention	During the intervention
Secondary	Usage of analgesics	Amount of used analgesics agents during the intervention	During the intervention
Secondary	Usage anti-vomiting agents	Amount of used anti-vomiting agents during the intervention	During the intervention
Secondary	Serum creatinine level	Serum creatinine (mg/dL)	1 hour pre-procedural, during the first 24 hours after the procedure
Secondary	Serum urea level	Serum urea (mg/dL)	1 hour pre-procedural, during the first 24 hours after the procedure
Secondary	eGFR	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.	1 hour pre-procedural, during the first 24 hours after the procedure
Secondary	Heart rate	Heart rate (frequency per minute) will be assessed by using a monitoring device	pre-intervention, and then every 15 minutes during the procedure
Secondary	Oxygen saturation	Oxygen saturation (%) will be assessed by using a monitoring device	pre-intervention, and then every 15 minutes during the procedure
Secondary	Blood pressure	Systolic and diastolic blood pressure (mmHg) will be assessed by using a monitoring device	pre-intervention, and then every 15 minutes during the procedure
Secondary	blood pH	Will be assessed by venous blood gas analysis (number).	1 hour pre-procedural
Secondary	blood PaCo2	Will be assessed by venous blood gas analysis (mmHg).	1 hour pre-procedural
Secondary	blood HCO3	Will be assessed by venous blood gas analysis (mEq/L).	1 hour pre-procedural
Secondary	blood sugar	Will be assessed by venous blood gas analysis (mg/dL).	1 hour pre-procedural, pre-intervention, 8 hours after procedure
Secondary	Sodium	Will be assessed by blood test.	1 hour pre-procedural, pre-intervention, 8 hours after procedure
Secondary	Potassium	Will be assessed by blood test (mm/L).	1 hour pre-procedural, pre-intervention, 8 hours after procedure
Secondary	Patients general satisfaction	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)	During the first 24 hours after the procedure
Secondary	Sleep quality	Sleep quality based on Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)	During the first 24 hours after the procedure
Secondary	Surgical site pain	Surgical site pain based on Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome)	During the first 24 hours after the procedure
Secondary	Length of ICU stay	Based on the number of ICU stay nights	Up to 30 days
Secondary	Length of hospital stay	Based on the number of ICU stay nights plus ward stay	Up to 30 days
Secondary	Operation site infection rate	Operation site (Chest) infection rate via Telephone /follow-up visits	During 30 days after the procedure
Secondary	Incidence of death	The investigators will then divide the causes into 1) operation related and 2) non-operation related causes	During 30 days after the procedure