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

NCT04370639 | Completed FDA Device

• 1 other identifier: 1498912
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Device Tolerability

  6 months.

• Accuracy

  6 months

Study Arms (1)

AccuFlow Sensor

EXPERIMENTAL

These 50 patients will wear the AccuFlow sensor device during their surgery, and will complete the post-procedural survey. The data will be reviewed after 25 patients, and the pilot study may be stopped at that point if it is felt that the device feasibility and tolerability have been adequately established.

Device: AccuFlow sensor; Other: Survey

Interventions

AccuFlow sensor DEVICE

AccuFlow sensor will be worn and survey completed

AccuFlow Sensor

Survey OTHER

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

AccuFlow Sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of allergy or other adverse reaction to adhesives
• Fever at the time of recruitment

Sponsors & Collaborators

• Megan Lord: lead
• ThermaSENSE Corp: collaborator

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (12)

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  PMID: 25103301 BACKGROUND

• LOW JA, JOHNSTON EE, MCBRIDE RL. BLOOD VOLUME ADJUSTMENTS IN THE NORMAL OBSTETRIC PATIENT WITH PARTICULAR REFERENCE TO THE THIRD TRIMESTER OF PREGNANCY. Am J Obstet Gynecol. 1965 Feb 1;91:356-63. doi: 10.1016/0002-9378(65)90250-4. No abstract available.

  PMID: 14258262 BACKGROUND

• Mutschler M, Paffrath T, Wolfl C, Probst C, Nienaber U, Schipper IB, Bouillon B, Maegele M. The ATLS((R)) classification of hypovolaemic shock: a well established teaching tool on the edge? Injury. 2014 Oct;45 Suppl 3:S35-8. doi: 10.1016/j.injury.2014.08.015.

  PMID: 25284231 BACKGROUND

• Chandra S, Tripathi AK, Mishra S, Amzarul M, Vaish AK. Physiological changes in hematological parameters during pregnancy. Indian J Hematol Blood Transfus. 2012 Sep;28(3):144-6. doi: 10.1007/s12288-012-0175-6. Epub 2012 Jul 15.

  PMID: 23997449 BACKGROUND

• Ashok Y, Roy PS, Goyal BK. ACUTE NORMOVOLEMIC HEMODILUTION IN PATIENTS UNDERGOING ELECTIVE MAJOR SURGERY. Med J Armed Forces India. 2000 Jul;56(3):216-218. doi: 10.1016/S0377-1237(17)30170-3. Epub 2017 Jun 10.

  PMID: 28790711 BACKGROUND

• Schiller AM, Howard JT, Convertino VA. The physiology of blood loss and shock: New insights from a human laboratory model of hemorrhage. Exp Biol Med (Maywood). 2017 Apr;242(8):874-883. doi: 10.1177/1535370217694099. Epub 2017 Jan 1.

  PMID: 28346013 BACKGROUND

• O'Brien TJ, Roghanizad AR, Jones PA, Aardema CH, Robertson JL, Diller TE. The Development of a Thin-Filmed Noninvasive Tissue Perfusion Sensor to Quantify Capillary Pressure Occlusion of Explanted Organs. IEEE Trans Biomed Eng. 2017 Jul;64(7):1631-1637. doi: 10.1109/TBME.2016.2615241. Epub 2016 Oct 5.

  PMID: 28113229 BACKGROUND

• Conner SN, Tuuli MG, Colvin R, Shanks AL, Macones GA, Cahill AG. Accuracy of Estimated Blood Loss in Predicting Need for Transfusion after Delivery. Am J Perinatol. 2015 Nov;32(13):1225-30. doi: 10.1055/s-0035-1552940. Epub 2015 May 22.

  PMID: 26007310 BACKGROUND

• Sylla RR, Lee KL. Correlating Quantitative Blood Loss and Estimated Blood Loss With Postoperative Change in Hematocrit After Cesarean Delivery [258]. Obstetrics & Gynecology. 2015;125:83S. doi:10.1097/01.aog.0000463235.89427.b3

  BACKGROUND

• PENNES HH. Analysis of tissue and arterial blood temperatures in the resting human forearm. J Appl Physiol. 1948 Aug;1(2):93-122. doi: 10.1152/jappl.1948.1.2.93. No abstract available.

  PMID: 18887578 BACKGROUND

• Moritz AR, Henriques FC. Studies of Thermal Injury: II. The Relative Importance of Time and Surface Temperature in the Causation of Cutaneous Burns. Am J Pathol. 1947 Sep;23(5):695-720. No abstract available.

  PMID: 19970955 BACKGROUND

• Knight JF, Baber C, Schwirtz A, Bristow HW. The comfort assessment of wearable computers. Proceedings Sixth International Symposium on Wearable Computers. doi:10.1109/iswc.2002.1167220

  BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Megan Lord, MD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 1, 2020
• Study Start: May 20, 2020
• Primary Completion: February 25, 2021
• Study Completion: February 28, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)