Hemorrhage Clinical Trial
Official title:
Non-Invasive Hemorrhage Monitoring: A Pilot Study to Assess the Feasibility and Tolerability of the AccuFlow Perfusion Sensor for the Detection of Intrapartum Hemorrhage
NCT number | NCT04370639 |
Other study ID # | 1498912 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2020 |
Est. completion date | February 28, 2021 |
Verified date | July 2021 |
Source | Women and Infants Hospital of Rhode Island |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obstetric hemorrhage is one of the leading causes of maternal death worldwide. One of the challenges in management of hemorrhage is that young, healthy women compensate for blood loss via peripheral vasoconstriction, so they maintain their blood pressure and heart rate at normal levels even after experiencing significant blood loss. By the time vital sign abnormalities appear, interventions must be performed extremely rapidly to avoid organ damage and maternal death. Clinical methods of estimating blood loss in real time, such as visual estimation, are notoriously unreliable, and changes in laboratory testing such as hemoglobin levels lag hours behind actual blood loss. A tool which can detect and quantify blood loss in real time, before vital sign changes occur, has the potential to allow for earlier mobilization of resources and intervention in these cases, thus saving lives. This device is meant to detect changes in skin blood flow which reflect vasoconstriction. The investigators believe that this device, therefore, has the potential to be able to detect and quantify blood loss in real-time. However, as this novel device has never been used for this purpose, before undertaking a large clinical trial, the investigators feel it is necessary to perform a pilot study to assess the feasibility and tolerability of this device. The investigators plan to test this by asking 50 patients undergoing planned cesarean section to wear the device during their surgery. The device will collect skin perfusion measurements during the surgery, which will not be available to the operating team. The patients will also be asked to complete a survey regarding their experience wearing the device. The investigators will use this information to ensure that the device is transmitting interpretable data, that patients feel the device is tolerable during surgery, and to ensure that the device can be used in the operating room without any unforeseen logistical challenges which would need to be addressed in planning a larger trial. The investigators will perform a preliminary comparison of sensor readings to laboratory findings, to assist in planning a larger trial.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - English speaking - Undergoing planned cesarean section at Women and Infants Hospital - BMI on admission less than or equal to 35 kg/m2 - Preoperative hemoglobin greater than or equal to 11.5g/dL on routine labs Exclusion Criteria: - History of allergy or other adverse reaction to adhesives - Fever at the time of recruitment |
Country | Name | City | State |
---|---|---|---|
United States | Women and Infants Hospital of Rhode Island | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Megan Lord | ThermaSENSE Corp |
United States,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improving sensor design and analysis | We will use the sensor readings obtained from this study to determine how best to obtain and analyze sensor readings in a larger trial. This will include comparing different ratios of readings (both different points in time during the case and different measurement sites on the patient) to determine the ideal number and locations of sensors, and ideal method of data analysis, for a larger trial. | 6 months | |
Secondary | Device Tolerability | Patients will be asked to complete a survey after their cesarean rating the tolerability of the device, as well as the tolerability of standard anesthesia monitoring equipment (blood pressure cuff and pulse oximeter), to assess how the tolerability of the novel device compares to equipment already in use. This will be done in this way because although there is a validated scale for tolerability of wearable computer devices, this scale is only validated as a comparison between two options, and no absolute threshold below which a device is considered "tolerable" has been established. | 6 months. | |
Secondary | Accuracy | We will compare the available device readings to the available lab measurements of hemorrhage, to determine if a difference is seen between patients with 10% blood volume lost vs 20% blood volume lost. This will assist in planning a larger trial by determining how many patients with higher-volume blood loss would need to be included, and therefore what total enrollment would likely be needed in the larger trial. | 6 months |
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