ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery

NCT05536258 | Completed DMC

• 1 other identifier: 22-340
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The trial groups will be:

1. 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. 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.

Conditions

Noncardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Identify absolute and relative changes of RI

  continuously monitor and obtain RI values throughout anesthesia and the post anesthesia care unit.

  PACU stay

Study Arms (1)

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

Interventions

Fluid OTHER

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.

RI-Monitoring

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Non-sinus heart rhythm;
• amputation of any extremity;
• eGFR \< 30 including end-stage kidney disease;
• cardiac ejection fraction \< 50;
• temporary or permanent pacemaker;
• BMI \> 40 kg/m2. -

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Kurt Ruetzler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: March 9, 2023
• Primary Completion: May 29, 2024
• Study Completion: June 24, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)