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Completed

NCT Number: NCT04706221

Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

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.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM-1500

Device

Blood volume monitor CM-1500

Primary outcomes

  1. Relative Index Change During PACU Stay

    Time frame: Length of PACU Stay (Range: 46 to 353 minutes)

    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.

Sponsors and collaborators

Lead sponsor

Zynex Monitoring Solutions

Industry

Collaborators

  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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