Blood Loss
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICECM-1500
Blood volume monitor CM-1500
Sponsors
Wake Forest University Health Sciences
Zynex Monitoring Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Index Change During PACU Stay | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Volume Monitoring Laparoscopic Surgery CM-1500: Blood volume monitor post-laparoscopic surgery | 98 |
| Blood Volume Monitoring - Open Surgery CM-1500: Blood volume monitor post-open surgery | 75 |
| Total | 173 |
Baseline characteristics
| Characteristic | Blood Volume Monitoring - Open Surgery | Total | Blood Volume Monitoring Laparoscopic Surgery |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 58 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 115 Participants | 70 Participants |
| Age, Continuous | 58.4 years STANDARD_DEVIATION 15.2 | 56.25 years STANDARD_DEVIATION 14.7 | 54.1 years STANDARD_DEVIATION 14.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 75 Participants | 173 Participants | 98 Participants |
| Sex: Female, Male Female | 40 Participants | 102 Participants | 62 Participants |
| Sex: Female, Male Male | 35 Participants | 71 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 75 |
| other Total, other adverse events | 0 / 98 | 0 / 75 |
| serious Total, serious adverse events | 0 / 98 | 0 / 75 |
Outcome results
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.
Time frame: Length of PACU Stay (Range: 46 to 353 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Volume Monitoring - Open Surgery | Relative Index Change During PACU Stay | -2.01 Relative Index (RI) | Standard Deviation 4 |
| Blood Volume Monitoring - Laparoscopic Surgery | Relative Index Change During PACU Stay | -1.32 Relative Index (RI) | Standard Deviation 3.11 |