Blood Loss, Surgical, Postoperative Hemorrhage
Conditions
Brief summary
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use during and after inpatient surgery. The device does not provide absolute clinical measurements. Researchers will also explore whether changes recorded by the device occur around signs or treatments related to blood loss. The main questions are: * Can the device collect usable information during and after surgery without interfering with routine care? * What device-related problems, such as skin irritation or discomfort, occur? * Do changes in the device measurements occur around changes in blood pressure, laboratory results, fluid administration, or blood transfusion? * How comfortable and practical is the device for participants and bedside nurses? Participants undergoing surgery will wear the device on the upper arm or chest. Trained study staff will apply it before surgery. It will remain in place for up to 48 hours after surgery, or until discharge or earlier removal. Participants will continue to receive usual hospital monitoring and care. Bedside nurses may also join the study and complete a short voluntary survey. Nurses may check the device position and adjust the strap for comfort. They will not interpret the device measurements or use them to make treatment decisions. Hemorai Vysio is an investigational device. Its measurements will be analyzed for research and will not be used to guide participants' medical care. Participants are not expected to receive a direct medical benefit from taking part.
Interventions
DEVICEWearable optical hemodynamic monitoring device
An investigational, non-FDA-approved strap-based wearable optical device placed on the upper arm or chest by trained study staff. It records intermittent 2-minute optical signal windows every 15 minutes during surgery and for up to 48 hours postoperatively. Research outputs include relative trends in local tissue oxygenation (StO2), hemoglobin-related signals, perfusion index (SFI), and tissue oxygen consumption (tMRO2). The device operates in parallel with standard-of-care monitoring; data are analyzed offline and are not used for clinical decisions.
Sponsors
Hemorai Inc
National Heart, Lung, and Blood Institute (NHLBI)
University of Massachusetts, Worcester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective, single-arm feasibility study with two consented participant populations. Approximately 60 adult surgical patients will wear the investigational Hemorai Vysio device during surgery and for up to 48 hours postoperatively. Enrollment exceeds 20 surgical participants because hemorrhage-protocol activation is expected in only a subset; approximately 60 surgical patients are planned to obtain about 20 with a qualifying activation during device wear. Approximately 20 bedside nurses will participate in workflow and usability surveys; they are not assigned the device. Total anticipated enrollment is 80. There is no comparator, crossover, randomization, blinding, or control arm. Vysio data are analyzed offline and do not guide clinical care.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Surgical participants: * 18 to 85 years of age * Undergoing inpatient surgery with an expected overnight hospital stay * Capable of providing informed consent * No anticipated contraindications to skin-worn sensors * Hemodynamically stable at enrollment, with no vasopressor requirement Nursing participants: * Bedside nurse caring for an enrolled surgical participant during the Vysio device-wear period * Capable of providing informed consent for the study-related usability survey * Willing to complete the voluntary usability survey
Exclusion criteria
Surgical participants: * Pregnancy; participants of childbearing potential with a positive pregnancy test before surgery * Prisoner * Cognitive impairment or inability to provide informed consent * Hemodynamic instability requiring vasopressors at enrollment * Severe dermatitis or another skin condition at the planned device application site * Known allergy or prior adverse reaction to silicone elastomer, thermoplastic elastomer, or components of the self-adherent elastic wrap (cotton/polyester substrate or synthetic elastic yarn) * Active skin breakdown, dermatitis, eczema, burns, or a surgical incision at the planned strap contact site * Condition compromising skin integrity such that the site would not qualify as intact skin under ISO 10993-1:2018 Nursing participants: * Not caring for an enrolled surgical participant during the Vysio device-wear period * Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of scheduled Vysio recording windows containing signal data | From device placement before surgery through device removal, up to approximately 54 hours | For each patient participant, the number of scheduled 2-minute Vysio recording windows containing recorded signal data will be divided by the number of scheduled windows during device wear and multiplied by 100. The percentage will be summarized descriptively across participants as a measure of device-data completeness. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElliot Servais, MD, FACS
Lahey Clinic, Inc.
Outcome results
None listed