Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

Blood Loss Clinical Trial

Official title:

Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706221
• Other study ID #: ZMS-1500-2001
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: November 29, 2021

Study information

• Verified date: February 2024
• Source: Zynex Monitoring Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.

Description:

Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. Monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent

• Ability and willingness to comply with study procedures and duration requirements

• 18 years of age or older

• Undergoing an abdominal or pelvic surgery within the next 10 days

Exclusion Criteria:

• Females who are pregnant or breastfeeding

• Participation in other clinical studies involving experimental drugs or devices

• Undergone an amputation of the left upper extremity

• Diagnosed with Dextrocardia

• Subjects who have a Pacemaker

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Device:
• CM-1500
Blood volume monitor CM-1500

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Zynex Monitoring Solutions	Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Index Change During PACU Stay	The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.	Length of PACU Stay (Range: 46 to 353 minutes)