NCT07473687

Brief Summary

This study aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require direct skin contact, which may pose risks of cross-infection or skin injury in vulnerable populations (e.g., newborns or elderly patients). This research utilizes remote Photoplethysmography (rPPG) technology to estimate vital signs, including heart rate, blood pressure, and blood oxygen saturation (SpO2), by analyzing facial video captured via standard camera devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra).The primary goal is to assess the consistency and stability of this non-contact system compared to clinical gold-standard monitors (Masimo Root, SedLine O3, and Radical-7) during actual surgical procedures. The findings will serve as a foundation for developing non-invasive, supplementary monitoring tools in dynamic clinical environments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Jun 2030

Study Start

First participant enrolled

January 8, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

February 3, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

General anesthesiaIntraoperative monitoringCamera-based monitorNon-contact Physiological MonitoringTotal Extraperitoneal Approach (TEP)Remote SensingPerioperative Care

Outcome Measures

Primary Outcomes (4)

  • Accuracy of Heart Rate (HR) monitoring

    The success rate of non-contact HR measurement using the rPPG software compared to the reference values from the Masimo Root clinical monitoring platform. A "success" is defined as an absolute error within +/- 3 bpm. Unit of Measure: Percentage of successful measurements (%)

    From anesthesia induction to recovery (approximately 2-6 hours).

  • Success rate of Systolic Blood Pressure (SBP) monitoring

    The success rate of non-contact SBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 12 mmHg. Unit of Measure: Percentage of successful measurements (%)

    From anesthesia induction to recovery (approximately 2-6 hours).

  • Success rate of Diastolic Blood Pressure (DBP) monitoring

    The success rate of non-contact DBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 10 mmHg. Unit of Measure: Percentage of successful measurements (%)

    From anesthesia induction to recovery (approximately 2-6 hours).

  • Success rate of Oxygen Saturation (SpO2) monitoring

    The success rate of non-contact SpO2 measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 8% (when SpO2 \>/= 80%) or +/- 15% (when SpO2 \< 80%). Unit of Measure: Percentage of successful measurements (%)

    From anesthesia induction to recovery (approximately 2-6 hours).

Secondary Outcomes (2)

  • Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platforms

    During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).

  • Mean Absolute Error (MAE) of Blood Pressure (SBP and DBP) across hardware platforms

    During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).

Study Arms (1)

Perioperative Monitoring Group

Surgical patients who will be monitored simultaneously using both the investigational non-contact rPPG software (installed on laptop and mobile devices) and standard clinical monitoring systems (Masimo Root, SedLine O3, and Radical-7) across different surgical phases.

Device: Non-contact rPPG software

Interventions

A non-invasive, video-based software utilizing remote Photoplethysmography (rPPG) technology to estimate heart rate, blood pressure, and SpO2 by analyzing facial video captured via camera-enabled devices.

Perioperative Monitoring Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.

You may qualify if:

  • Patients aged \>18 years.
  • Patients scheduled to undergo surgical procedures under general anesthesia.
  • American Society of Anesthesiologists (ASA) Physical Status I, II, or III.

You may not qualify if:

  • Patients aged \< 18 years.
  • Pregnant patients.
  • Patients whose facial images cannot be captured or recognized (e.g., due to surgical drapes, severe edema, or major trauma).
  • Patients who refuse to participate or have not signed the informed consent form.
  • Other cases deemed unsuitable for the study by the clinical physician or anesthesiologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (8)

  • Fujimori S. Gastric acid level of humans must decrease in the future. World J Gastroenterol. 2020 Nov 21;26(43):6706-6709. doi: 10.3748/wjg.v26.i43.6706.

    PMID: 33268958BACKGROUND
  • Greenstein VC, Eggers HM, Hood DC. Multifocal visual evoked potential and automated perimetry abnormalities in strabismic amblyopes. J AAPOS. 2008 Feb;12(1):11-7. doi: 10.1016/j.jaapos.2007.04.017. Epub 2007 Jul 24.

    PMID: 17651996BACKGROUND
  • Xing L, Dai W, Zhang Y. Scheimpflug Camera-Based Technique for Multi-Point Displacement Monitoring of Bridges. Sensors (Basel). 2022 May 27;22(11):4093. doi: 10.3390/s22114093.

    PMID: 35684714BACKGROUND
  • Garcia-Fontana C, Corral Lugo A, Krell T. Specificity of the CheR2 methyltransferase in Pseudomonas aeruginosa is directed by a C-terminal pentapeptide in the McpB chemoreceptor. Sci Signal. 2014 Apr 8;7(320):ra34. doi: 10.1126/scisignal.2004849.

    PMID: 24714571BACKGROUND
  • Mismetti P, Rivron-Guillot K, Moulin N. [Vena cava filters and treatment of venous thromboembolism in cancer patients]. Pathol Biol (Paris). 2008 Jun;56(4):229-32. doi: 10.1016/j.patbio.2008.03.002. Epub 2008 May 5. French.

    PMID: 18456434BACKGROUND
  • Wallach JB, McGarry T, Torres J. Lymphangitic metastasis of recurrent renal cell carcinoma to the contralateral lung causing lymphangitic carcinomatosis and respiratory symptoms. Curr Oncol. 2011 Jan;18(1):e35-7. doi: 10.3747/co.v18i1.647.

    PMID: 21331270BACKGROUND
  • Lee KJ, Liu S, Parmigiani F, Ibsen M, Petropoulos P, Gallo K, Richardson DJ. OTDM to WDM format conversion based on quadratic cascading in a periodically poled lithium niobate waveguide. Opt Express. 2010 May 10;18(10):10282-8. doi: 10.1364/OE.18.010282.

    PMID: 20588881BACKGROUND
  • Wada M, Hara H, Nakamura M. A change in the pattern of vasospasm after stenting in a patient with vasospastic angina. Heart Vessels. 2006 Nov;21(6):388-91. doi: 10.1007/s00380-006-0920-6. Epub 2006 Nov 27.

    PMID: 17143717BACKGROUND

Related Links

MeSH Terms

Conditions

CholecystitisLiver NeoplasmsCholelithiasisHernia, Inguinal

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsLiver DiseasesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hui-Hsuan Ke

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

March 16, 2026

Study Start

January 8, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2030

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations