ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery
The trial groups will be: 1. Routine fluid management. Clinicians will be blinded to RI monitoring and use clinical judgement to determine how much fluids should be given, and when. Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, and heart rate. 2. RI-guided fluid administration. RI fluid guidance will be initiated before anesthesia induction and will maintain until end of anesthesia. Clinicians will titrate fluids with the goal of keeping RI above 90- always using good clinical judgement for individual patients which may include avoiding fluid when RI is \<90 or giving additional fluid when RI \>90. For RI scores below 90, 1 cc/kg actual body weight fluid bolus of any crystalloid solution (normal saline or Ringer's lactate) will be given; colloids and blood products can also be given if clinically indicated. The target will be maintained until end of anesthesia. Anesthesia will be maintained for the entire surgical procedure per clinical routine. At the end of the surgical procedure, patients will be extubated and transferred to the post anesthesia care unit (PACU).
Conditions:
🦠 Noncardiac Surgery
🗓️ Study Start (Actual) 9 March 2023
🗓️ Primary Completion (Estimated) 29 May 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 50
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Adults having major non-cardiac surgery expected to last ≥2 hours
    • 2. American Society of Anesthesiologists physical status 1-3
    • 3. Age 21-85 years old
    • 4. Planned endotracheal intubation and general anesthesia with or without any regional blocks.

    Exclusion Criteria:

    • 1. Non-sinus heart rhythm;
    • 2. amputation of any extremity;
    • 3. eGFR \< 30 including end-stage kidney disease;
    • 4. cardiac ejection fraction \< 50;
    • 5. temporary or permanent pacemaker;
    • 6. BMI \> 40 kg/m2. -
Ages Eligible for Study: 21 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 September 2022
  • First Submitted that Met QC Criteria 7 September 2022
  • First Posted 10 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 8 July 2024
  • Last Verified July 2024