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Completed

NCT Number: NCT04389697

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

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

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Key information

Conditions

Cardiac Implantable Electronic Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Electrophysiology, Leipzig Heart Center

Leipzig, Saxony, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 start of the procedure

Primary outcomes

  1. Patients well-being

    Time frame: 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 outcomes

  1. Usages of inotropic and vasopressor agents

    Time frame: During the intervention

    Amount of used inotropic and vasopressor agents during the intervention

  2. Usage of sedatives

    Time frame: During the intervention

    Amount of used sedative agents during the intervention

  3. Usage of analgesics

    Time frame: During the intervention

    Amount of used analgesics agents during the intervention

  4. Usage anti-vomiting agents

    Time frame: During the intervention

    Amount of used anti-vomiting agents during the intervention

  5. Serum creatinine level

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

    Serum creatinine (mg/dL)

  6. Serum urea level

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

    Serum urea (mg/dL)

  7. eGFR

    Time frame: 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.

  8. Heart rate

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

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

  9. Oxygen saturation

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

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

  10. Blood pressure

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

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

  11. blood pH

    Time frame: 1 hour pre-procedural

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

  12. blood PaCo2

    Time frame: 1 hour pre-procedural

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

  13. blood HCO3

    Time frame: 1 hour pre-procedural

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

  14. blood sugar

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

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

  15. Sodium

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

    Will be assessed by blood test.

  16. Potassium

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

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

  17. Patients general satisfaction

    Time frame: 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)

  18. Sleep quality

    Time frame: During the first 24 hours after the procedure

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

  19. Surgical site pain

    Time frame: 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)

  20. Length of ICU stay

    Time frame: Up to 30 days

    Based on the number of ICU stay nights

  21. Length of hospital stay

    Time frame: Up to 30 days

    Based on the number of ICU stay nights plus ward stay

  22. Operation site infection rate

    Time frame: During 30 days after the procedure

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

  23. Incidence of death

    Time frame: During 30 days after the procedure

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

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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