Cardiac Implantable Electronic Devices
Conditions
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
Interventions
DIETARY_SUPPLEMENTClear 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
Sponsors
Helios Health Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Usages of inotropic and vasopressor agents | During the intervention | Amount of used inotropic and vasopressor agents during the intervention |
| 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 |
| blood HCO3 | 1 hour pre-procedural | Will be assessed by venous blood gas analysis (mEq/L). |
Countries
Germany
Outcome results
None listed