NCT04370639

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

Completed NA Last updated 13 July 2021

What this trial tests

NA trial testing AccuFlow sensor in Hemorrhage, Postpartum in 25 participants. Completed in 28 February 2021.

Timeline

20 May 2020

Primary endpoint
25 February 2021

28 February 2021

Quick facts

Lead sponsor	Megan Lord
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	20 May 2020
Primary completion	25 February 2021
Estimated completion	28 February 2021
Sites	1 location across United States

Drugs / interventions tested

• AccuFlow sensor
• Survey

Conditions studied

• Hemorrhage, Postpartum — all drugs for Hemorrhage, Postpartum →
• Hemorrhage — all drugs for Hemorrhage →
• Vasoconstriction — all drugs for Vasoconstriction →

Sponsor

Megan Lord

Who can join

18 and older, female only, with Hemorrhage, Postpartum or Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.