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

Helios Health Institute GmbH201 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

201

Conditions

Cardiac Implantable Electronic Devices

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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)

Time frame: During the first 24 hours after the procedure

Secondary Outcomes

Usages of inotropic and vasopressor agents

Amount of used inotropic and vasopressor agents during the intervention

Time frame: During the intervention

Usage of sedatives

Amount of used sedative agents during the intervention

Time frame: During the intervention

Usage of analgesics

Amount of used analgesics agents during the intervention

Time frame: During the intervention

Usage anti-vomiting agents

Amount of used anti-vomiting agents during the intervention

Time frame: During the intervention

Serum creatinine level

Serum creatinine (mg/dL)

Time frame: 1 hour pre-procedural, during the first 24 hours after the procedure

Serum urea level

Serum urea (mg/dL)

Time frame: 1 hour pre-procedural, during the first 24 hours after the procedure

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.

Time frame: 1 hour pre-procedural, during the first 24 hours after the procedure

Heart rate

Heart rate (frequency per minute) will be assessed by using a monitoring device

Time frame: pre-intervention, and then every 15 minutes during the procedure

Oxygen saturation

Oxygen saturation (%) will be assessed by using a monitoring device

Time frame: pre-intervention, and then every 15 minutes during the procedure

Blood pressure

Systolic and diastolic blood pressure (mmHg) will be assessed by using a monitoring device

Time frame: pre-intervention, and then every 15 minutes during the procedure

blood pH

Will be assessed by venous blood gas analysis (number).

Time frame: 1 hour pre-procedural

blood PaCo2

Will be assessed by venous blood gas analysis (mmHg).

Time frame: 1 hour pre-procedural

blood HCO3

Will be assessed by venous blood gas analysis (mEq/L).

Time frame: 1 hour pre-procedural

blood sugar

Will be assessed by venous blood gas analysis (mg/dL).

Time frame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure

Sodium

Will be assessed by blood test.

Time frame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure

Potassium

Will be assessed by blood test (mm/L).

Time frame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure

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)

Time frame: During the first 24 hours after the procedure

Sleep quality

Sleep quality based on Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)

Time frame: During the first 24 hours after the procedure

Surgical site pain

Surgical site pain based on Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome)

Time frame: During the first 24 hours after the procedure

Length of ICU stay

Based on the number of ICU stay nights

Time frame: Up to 30 days

Length of hospital stay

Based on the number of ICU stay nights plus ward stay

Time frame: Up to 30 days

Operation site infection rate

Operation site (Chest) infection rate via Telephone /follow-up visits

Time frame: During 30 days after the procedure

Incidence of death

The investigators will then divide the causes into 1) operation related and 2) non-operation related causes

Time frame: During 30 days after the procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes