Patient SafetyNCT07846644
Evaluating a Fingerprint System to Improve Patient Identification in Cardiac Surgery
An observational study of Patient Safety, run by Heuristik Technologies SL.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety
- What is being tested?
- Heuristik Fingerprint Identification System
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Evaluation of a Heuristik Fingerprint-Based Patient Identification System for Enhancing Patient Safety in Cardiac Surgery Workflows at Brigham and Women's Hospital
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
- Being tested
- Heuristik Fingerprint Identification System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heuristik Fingerprint Identification SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Heuristik Fingerprint Identification System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).
Secondary outcomes (2)
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.
Measured: Through study completion, up to 6 months.
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.
Measured: Through participant hospital discharge (estimated up to 30 days per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heuristik Technologies SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846644
- Sponsor's protocol ID
- 2025P003404
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Heuristik Fingerprint-Based Patient Identification System for Enhancing Patient Safety in Cardiac Surgery Workflows at Brigham and Women's Hospital
- ClinicalTrials.gov ID
- NCT07846644
- Acronym / sponsor ID
- 2025P003404
- Conditions
- Patient Safety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Heuristik Technologies SLIndustry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery Patients | – | Other: Heuristik Fingerprint Identification SystemAdult 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. |
| Healthcare Professionals | – | Other: Heuristik Fingerprint Identification SystemClinical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heuristik Fingerprint Identification SystemThe 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. | Other | Cardiac Surgery Patients, Healthcare Professionals |
Primary outcome
Identification Concordance Rate Between Biometric Fingerprint Scanning and Standard Hospital Wristband Verification
Time frame: Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).
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 Required for Patient Identification Scan Measured in Seconds
Time frame: Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).
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).
2 secondary outcomes
System Usability Scale (SUS) Score
Time frame: Through study completion, up to 6 months.
Patient Satisfaction and Acceptance Survey Score
Time frame: Through participant hospital discharge (estimated up to 30 days per participant).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by Heuristik Technologies SL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification Concordance Rate Between Biometric Fingerprint Scanning and Standard Hospital Wristband Verification (time frame: Through participant hospital discharge, assessed at 5 perioperative checkpoints (estimated up to 30 days per participant).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.