Evaluating a Fingerprint System to Improve Patient Identification in Cardiac Surgery

NCT07846644 | Not Yet Recruiting

• 1 other identifier: 2025P003404
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patient Safety

Outcome Measures

Primary Outcomes (2)

• 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).

  Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).

• 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).

  Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).

Secondary Outcomes (2)

• System Usability Scale (SUS) Score

  Through study completion, up to 6 months.

• Patient Satisfaction and Acceptance Survey Score

  Through participant hospital discharge (estimated up to 30 days per participant).

Study Arms (2)

Cardiac Surgery Patients

Adult patients undergoing perioperative cardiac surgery care at Brigham and Women's Hospital (n=50). Biometric identification using the Heuristik fingerprint system is evaluated in parallel with standard hospital wristband identification across clinical checkpoints.

Other: Heuristik Fingerprint Identification System

Healthcare Professionals

Clinical and administrative staff (n=15), including cardiac surgeons, cardiologists, nurses, perfusionists, and clinical support staff, operating the biometric system. Participants evaluate system usability through the System Usability Scale (SUS) and semi-structured interviews.

Other: Heuristik Fingerprint Identification System

Interventions

Heuristik Fingerprint Identification System OTHER

The 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.

Cardiac Surgery Patients; Healthcare Professionals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Patient Cohort:
• 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.
• Healthcare Professional Cohort:
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heuristik Technologies SL: lead
• Brigham and Women's Hospital: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09