Noncardiac SurgeryNCT05536258
ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery
An observational study of Noncardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Noncardiac Surgery
- What is being tested?
- Fluid
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 24 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery
The trial groups will be:
- 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.
- 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).
Read the 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:
- 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.
- 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
- Being tested
- Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Other: Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify absolute and relative changes of RI
continuously monitor and obtain RI values throughout anesthesia and the post anesthesia care unit.
Measured: PACU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start9 Mar 2023
- Primary completion29 May 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noncardiac SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Ruetzler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536258
- Sponsor's protocol ID
- 22-340
- Status last verified
- Jul 2025
- First submitted
- 7 Sep 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT05536258
- Acronym / sponsor ID
- 22-340
- Conditions
- Noncardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial groups will be:
- 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.
- 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).
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:
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RI-Monitoring | – | Other: FluidThe 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; |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Non-sinus heart rhythm;
- amputation of any extremity;
- eGFR < 30 including end-stage kidney disease;
- cardiac ejection fraction < 50;
- temporary or permanent pacemaker;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluidThe 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 | RI-Monitoring |
Primary outcome
Identify absolute and relative changes of RI
Time frame: PACU stay
continuously monitor and obtain RI values throughout anesthesia and the post anesthesia care unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Related trials for Noncardiac Surgery
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Not yet recruitingPhase 4
Intranasal Dexmedetomidine-esketamine Combination and Postoperative Cognitive Recovery in Older Patients
Older Patients, Noncardiac Surgery
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Not yet recruitingObservational study
Nerve Block and Perioperative Myocardial Injury in Elderly Hip Fracture
Hip Fracture, Perioperative Myocardial Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Ruetzler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noncardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify absolute and relative changes of RI (time frame: PACU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.