A Pilot Study to Assess the Feasibility and Tolerability of the AccuFlow Perfusion Sensor for Intrapartum Hemorrhage

Summary

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.

Conditions

• Hemorrhage, Postpartum
• Hemorrhage
• Vasoconstriction

Interventions

DEVICE

AccuFlow sensor

AccuFlow sensor will be worn and survey completed

OTHER

Survey

Patients will be asked to complete a survey regarding device tolerability after completing their cesarean section.

Sponsors & Collaborators

• ThermaSENSE Corp

  collaborator UNKNOWN

• Megan Lord

  lead OTHER

Principal Investigators

• Megan Lord, MD · Women and Infants Hospital of Rhode Island

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-05-20

Primary Completion

2021-02-25

Completion

2021-02-28

FDA Device

Yes

Countries

• United States

Study Locations