ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery

Evaluation of the 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).

Study Overview

• Status: Recruiting
• Conditions: Noncardiac Surgery
• Intervention / Treatment: Other: Fluid

Detailed Description

Patients will be premedicated with 0-2 mg midazolam per preference of the attending anesthesiologist. General anesthesia will be induced as preferred by the attending anesthesiologist, usually with a combination of lidocaine 1 mg/kg, propofol 1-4 mg/kg, fentanyl 1-2 µg/kg, and rocuronium 0.6-1.2 mg/kg or succinylcholine 1.5 mg/kg. The trachea will be intubated, and the lungs mechanically ventilated per clinical routine. General anesthesia will be maintained with an initial sevoflurane target concentration of 0.8% which will be adjusted based on apparent clinical need, supplemented with fentanyl. Vasopressors, antihypertensives, and drugs to control heart rate may be given as clinically indicated. BIS will be recorded to estimate hypnotic depth.

Patients will be randomized 1:1, stratified for chronic use of antihypertensive medication, in random-sized blocks to RI-guided fluid management or routine care. The randomization table will be prepared by trial statisticians, and allocation will be concealed until shortly before anesthetic induction with a web-based randomization system. The Zynex RI system will be applied and calibrated before anesthetic induction in all patients. A continuous fluid infusion of 1cc/ kg actual body weight/hour of crystalloid solution will be started in all patients before anesthesia induction and maintained until end of anesthesia. 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).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Roberta Johnson; Phone Number: 216-444-9950; Email: johnsor13@ccf.org
• Study Contact Backup: Name: Valentina Lara-Erazo, MD; Email: Larav2@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Roberta Johnson; Phone Number: 216-444-9950; Email: johnsor13@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients having major non-cardiac surgery expected to last ≥2 hours. The ASA physical status 1-3, and their age 21-85 years old. The patient should have a planned endotracheal intubation and general anesthesia with or without any regional blocks.

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. -

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

RI-Monitoring; The investigator will evaluate the feasibility of a RI-guided fluid ministration for improving perioperative characteristics. Feasibility will be defined by: The investigators will titrate fluid administration to maintain a RI > 90 over at least 85% of the intraoperative period lasting from induction until the end of anesthesia. Specifically, the investigator will consider titration to have been successful if 85% of patients in the RI group sustain a RI > 90 over at least 85% of the intraoperative period;

Other: Fluid; The investigators will titrate fluid administration to maintain a RI > 90 over at least 85% of the intraoperative period lasting from induction until the end of anesthesia. Specifically, the investigator will consider titration to have been successful if 85% of patients in the RI group sustain a RI > 90 over at least 85% of the intraoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify absolute and relative changes of RI	continuously monitor and obtain RI values throughout anesthesia and the post anesthesia care unit.	PACU stay

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kurt Ruetzler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-340

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes