Evaluating a Fingerprint System to Improve Patient Identification in Cardiac Surgery
ConditionPatient Safety
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeuristik Technologies SL
About this trial
The purpose of this prospective observational pilot study is to evaluate the usability, workflow integration, and operational feasibility of a fingerprint-based patient identification system (the Heuristik system) within perioperative cardiac surgery care. Accurate patient identification is a critical component of safe surgical care, particularly in high-acuity environments such as cardiac surgery where patients may be sedated or unable to actively confirm their identity. This study evaluates whether biometric fingerprint identification can function as a reliable adjunct to standard hospital identification methods. Adult patients receiving cardiac surgery care at Brigham and Women's Hospital will continue to be identified using the hospital's mandatory standard procedures, such as wristband verification. In parallel, participating clinical staff will use the fingerprint device for research evaluation at routine identification checkpoints, including admission, pre-operative preparation, surgical safety time-out, post-operative recovery, and discharge. The research team will observe workflow timing metrics and evaluate system accuracy compared to standard wristband checks. Participating healthcare professionals will complete a standardized System Usability Scale (SUS) questionnaire and a brief interview to provide feedback on ease of use, acceptability, and workflow fit. The study is observational and does not alter medical care, clinical decision-making, or treatment plans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 18 years or older) scheduled for or undergoing perioperative cardiac surgery care at Brigham and Women's Hospital.
Able and willing to provide written informed consent.
Clinical or administrative staff members involved in perioperative cardiac surgery care at Brigham and Women's Hospital (e.g., cardiac surgeons, cardiologists, nurses, perfusionists, clinical support staff).
Willingness to operate the biometric solution during routine clinical workflows and complete usability evaluations (System Usability Scale questionnaire and interview).
Disqualifiers
Individuals under 18 years of age.
Patients with severe anatomical deformities, extensive skin trauma, burns, or active lesions affecting all digits that preclude biometric fingerprint scanning.
Inability or unwillingness to provide informed consent.
Trial population
Adult patients admitted for perioperative cardiac surgery care at Brigham and Women's Hospital, as well as the multidisciplinary clinical staff responsible for their perioperative care and identification workflows.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Heuristik Fingerprint Identification System
Other interventionThe technology used in this study is a fingerprint-based biometric patient identification device and associated software platform. The device captures fingerprint-derived biometric data and generates encrypted biometric templates used to verify patient identity at predefined points within perioperative clinical workflows. The technology is used solely for research evaluation purposes, including the assessment of usability, feasibility, workflow integration, identification accuracy, and time efficiency. The solution does not integrate with electronic medical records or influence clinical decision-making or patient care. In this study, cardiac surgery patients are the subjects of biometric identification, while participating healthcare professionals act as the operators of the system to evaluate its usability and workflow integration.
Treatment groups
65 Participants
are divided into 2 treatment groupsGroup A: Cardiac Surgery Patients1 intervention
Group B: Healthcare Professionals1 intervention
Trial outcomes
Primary outcomes
1
Identification Concordance Rate Between Biometric Fingerprint Scanning and Standard Hospital Wristband Verification
Percentage of successful patient identification matches achieved by the Heuristik fingerprint system when verified against standard hospital wristband identification at 5 perioperative checkpoints (admission, pre-operative preparation, surgical safety time-out, PACU, and discharge).
Time frame
Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).2
Time Required for Patient Identification Scan Measured in Seconds
The time duration, measured in seconds using a digital stopwatch, required by clinicians to complete a patient identification attempt using the Heuristik fingerprint biometric system at 5 perioperative checkpoints (admission, pre-operative preparation, surgical safety time-out, PACU, and discharge).
Time frame
Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).Secondary outcomes
1
System Usability Scale (SUS) Score
System usability and operator acceptability evaluated by participating healthcare professionals using the validated 10-item System Usability Scale (SUS). Total scores range from 0 to 100, where higher scores represent better system usability.
Time frame
Through study completion, up to 6 months.2
Patient Satisfaction and Acceptance Survey Score
Patient acceptability and satisfaction regarding fingerprint biometric identification, evaluated via a structured patient satisfaction survey across all 5 perioperative contact points (admission, pre-operative preparation, surgical safety time-out, PACU, and discharge). The survey assesses patient-reported comfort, privacy concerns, and overall acceptance of biometric identification. Total scores range from 1 to 5 (on a 5-point Likert scale), where higher scores represent higher patient satisfaction and acceptance.
Time frame
Through participant hospital discharge (estimated up to 30 days per participant).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Heuristik Technologies SL
Lead sponsor
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov
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