Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05536258
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2022-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Evaluation of the ZYNEX Cardiac Monitor in Patients Having Noncardiac Surgery
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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).
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).
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: