AnesthesiaNCT05023356
Non-contact Vital Signs Monitoring in Anesthesia
An observational study of Anesthesia and Vital Signs, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
The purpose of this study is to monitor vital signs with contact and non-contact monitors in patients during anesthesia, and analyze the signal differences between the two monitors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia, Vital Signs, Monitors
- What is being tested?
- Non-contact vital signs monitoring with camera
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2021to 23 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 20, ASA class I~II who accept scheduled anesthesia and surgery in single medical center are enrolled in this study.
Who may be able to join
- over the age of 20.
- American Society of Anesthesiologists (American Society of Anesthesiologists, ASA) anesthesia risk class l (healthy people, except for the surgical correction part, no systemic disease, mortality before and after surgery 0.06~0.08%) and ASA class II patients (with mild systemic disease but no functional impairment, and the mortality rate before and after surgery is 0.27~0.4%).
Who cannot join
- under the age of 20
- pregnant patients
- those who refuse to participate in the research or are unwilling to sign the consent form due to any factors
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to monitor vital signs with contact and non-contact monitors in patients during anesthesia, and analyze the signal differences between the two monitors.
Read the detailed description
The standard vital signs routinely monitored in patients during anesthesia include heart rate, electrocardiogram, blood pressure, body temperature, respiratory rate, and peripheral blood oxygen saturation, and etc. Continuous measurement and interpretation of these vital signs can provide important information about the underlying physiological state.
Conventional techniques for tracking vital signs require physical contact, and most techniques are invasive. Body contact with sensors (for example, electrocardiograph electrodes) can irritate or damage the patient's skin, interfere with the patient's treatment or comfort, provide a vector for infection and cross-contamination, and only hinder mobility. In addition, when placing the sensor/wire on the body, the patient may feel uncomfortable (for example, anxiety, tension, and excitement). This negative experience may change the patient's breathing and heart rate and produce misleading results for medical service providers. Therefore, people need effective sensing methods that can wirelessly (non-contact/remote) monitor vital signs.
Since the 1970s, researchers have been looking for ways to conduct non-contact monitoring of vital signs. The following important medical situations have promoted continuous research in this field: (1) The patient's skin is fragile or vulnerable, such as low birth weight. , Premature infants, burn patients; (2) monitor wiring can endanger or interfere with patients, such as: Infant Death Syndrome and sleep apnea; (3) cross-contamination between patients (such as reusable wires) . The non-contact life monitoring technology does not involve electrodes or adhesives, does not touch the skin, does not have the risk of wires, entanglements or patient discomfort, does not consume any consumables, and there is no chance of cross-infection caused by inadequately disinfected equipment.
Today, advances in sensing technology have enabled smart systems to monitor vital signs, such as respiration and heart rate, in a non-contact manner. The two most advanced non-contact vital signs monitoring methods are the use of radio frequency (radar) and imaging (camera). In the past 15 years, the development of camera technology has increased its applicability and affordability, making people more and more interested in using these technologies in medical institutions. Monitoring methods using images can measure multiple vital signs at the same time and are relevant. The research has been applied to many ethnic groups, including sleeping healthy people, intensive care unit patients, kidney dialysis patients, and fibromyalgia patients.
- Conditions
- Anesthesia, Vital Signs, Monitors
- Being tested
- Non-contact vital signs monitoring with camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contact vital signs monitoring with cameraDevice
Monitor patients face image by non-contact vital signs monitoring with camera
| Study group | Role | What they receive |
|---|---|---|
| Contact vital signs monitoring | Routine monitors with cables | |
| Non-contact vital signs monitoring | Camera Receives: Device: Non-contact vital signs monitoring with camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal similarities
After analyzing signals from contact and non-contact vital signs monitors in the same group of patients in anesthesia, we could find out some signal consistency.
Measured: During anesthesia procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start10 Sep 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion23 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wen-Chuan Kuo, PhD, Principal investigator, Institute of Biophotonics, National Yang Ming Chiao Tung University, TaiwanChien-Kun Ting, PhD, Principal investigator, Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023356
- Sponsor's protocol ID
- 2021-05-024CC
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be constructed for business model.
Publications
Matthews G, Sudduth B, Burrow M. A non-contact vital signs monitor. Crit Rev Biomed Eng. 2000;28(1-2):173-8. doi: 10.1615/critrevbiomedeng.v28.i12.290.
PubMed 10999382Luo J, Yan Z, Guo S, Chen W. Recent Advances in Atherosclerotic Disease Screening Using Pervasive Healthcare. IEEE Rev Biomed Eng. 2022;15:293-308. doi: 10.1109/RBME.2021.3081180. Epub 2022 Jan 20.
PubMed 34003754Chen KM, Misra D, Wang H, Chuang HR, Postow E. An X-band microwave life-detection system. IEEE Trans Biomed Eng. 1986 Jul;33(7):697-701. doi: 10.1109/TBME.1986.325760. No abstract available.
PubMed 3733127Ke HH, Ting CK, Huang YM, Hung JC, Lai PY, Shih CX, Su HR, Kuo WC. Camera-Based Photoplethysmography for Measuring Heartbeat Intervals During General Anesthesia. Anesth Analg. 2025 Dec 1;141(6):1363-1372. doi: 10.1213/ANE.0000000000007635. Epub 2025 Aug 5.
PubMed 40763076
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-contact Vital Signs Monitoring in Anesthesia
- ClinicalTrials.gov ID
- NCT05023356
- Acronym / sponsor ID
- 2021-05-024CC
- Conditions
- Anesthesia, Vital Signs, Monitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 10 Sep 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 23 May 2022 (estimated)
- First posted
- 26 Aug 2021 (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 study is to monitor vital signs with contact and non-contact monitors in patients during anesthesia, and analyze the signal differences between the two monitors.
Detailed description
The standard vital signs routinely monitored in patients during anesthesia include heart rate, electrocardiogram, blood pressure, body temperature, respiratory rate, and peripheral blood oxygen saturation, and etc. Continuous measurement and interpretation of these vital signs can provide important information about the underlying physiological state.
Conventional techniques for tracking vital signs require physical contact, and most techniques are invasive. Body contact with sensors (for example, electrocardiograph electrodes) can irritate or damage the patient's skin, interfere with the patient's treatment or comfort, provide a vector for infection and cross-contamination, and only hinder mobility. In addition, when placing the sensor/wire on the body, the patient may feel uncomfortable (for example, anxiety, tension, and excitement). This negative experience may change the patient's breathing and heart rate and produce misleading results for medical service providers. Therefore, people need effective sensing methods that can wirelessly (non-contact/remote) monitor vital signs.
Since the 1970s, researchers have been looking for ways to conduct non-contact monitoring of vital signs. The following important medical situations have promoted continuous research in this field: (1) The patient's skin is fragile or vulnerable, such as low birth weight. , Premature infants, burn patients; (2) monitor wiring can endanger or interfere with patients, such as: Infant Death Syndrome and sleep apnea; (3) cross-contamination between patients (such as reusable wires) . The non-contact life monitoring technology does not involve electrodes or adhesives, does not touch the skin, does not have the risk of wires, entanglements or patient discomfort, does not consume any consumables, and there is no chance of cross-infection caused by inadequately disinfected equipment.
Today, advances in sensing technology have enabled smart systems to monitor vital signs, such as respiration and heart rate, in a non-contact manner. The two most advanced non-contact vital signs monitoring methods are the use of radio frequency (radar) and imaging (camera). In the past 15 years, the development of camera technology has increased its applicability and affordability, making people more and more interested in using these technologies in medical institutions. Monitoring methods using images can measure multiple vital signs at the same time and are relevant. The research has been applied to many ethnic groups, including sleeping healthy people, intensive care unit patients, kidney dialysis patients, and fibromyalgia patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact vital signs monitoring | – | –Routine monitors with cables |
| Non-contact vital signs monitoring | – | Device: Non-contact vital signs monitoring with cameraCamera |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 20, ASA class I~II who accept scheduled anesthesia and surgery in single medical center are enrolled in this study.
Key inclusion criteria (2 listed)
- over the age of 20.
- American Society of Anesthesiologists (American Society of Anesthesiologists, ASA) anesthesia risk class l (healthy people, except for the surgical correction part, no systemic disease, mortality before and after surgery 0.06~0.08%) and ASA class II patients (with mild systemic disease but no functional impairment, and the mortality rate before and after surgery is 0.27~0.4%).
Key exclusion criteria (3 listed)
- under the age of 20
- pregnant patients
- those who refuse to participate in the research or are unwilling to sign the consent form due to any factors
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 |
|---|---|---|
| Non-contact vital signs monitoring with cameraMonitor patients face image by non-contact vital signs monitoring with camera | Device | Non-contact vital signs monitoring |
Primary outcome
Signal similarities
Time frame: During anesthesia procedure
After analyzing signals from contact and non-contact vital signs monitors in the same group of patients in anesthesia, we could find out some signal consistency.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Background: PubMed 10999382Matthews G, Sudduth B, Burrow M. A non-contact vital signs monitor. Crit Rev Biomed Eng. 2000;28(1-2):173-8. doi: 10.1615/critrevbiomedeng.v28.i12.290.
- Background: PubMed 34003754Luo J, Yan Z, Guo S, Chen W. Recent Advances in Atherosclerotic Disease Screening Using Pervasive Healthcare. IEEE Rev Biomed Eng. 2022;15:293-308. doi: 10.1109/RBME.2021.3081180. Epub 2022 Jan 20.
- Background: PubMed 3733127Chen KM, Misra D, Wang H, Chuang HR, Postow E. An X-band microwave life-detection system. IEEE Trans Biomed Eng. 1986 Jul;33(7):697-701. doi: 10.1109/TBME.1986.325760. No abstract available.
- Derived from this study: PubMed 40763076Ke HH, Ting CK, Huang YM, Hung JC, Lai PY, Shih CX, Su HR, Kuo WC. Camera-Based Photoplethysmography for Measuring Heartbeat Intervals During General Anesthesia. Anesth Analg. 2025 Dec 1;141(6):1363-1372. doi: 10.1213/ANE.0000000000007635. Epub 2025 Aug 5.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be constructed for business model.
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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. This study is not recruiting at the moment.
Wen-Chuan Kuo, PhD principal investigator
Institute of Biophotonics, National Yang Ming Chiao Tung University, Taiwan
Chien-Kun Ting, PhD principal investigator
Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Vital Signs, run by Taipei Veterans General Hospital, Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Hsuan Ke, MD (+886-939196809, kehuihsuan0221@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal similarities (time frame: During anesthesia procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023356, which also lists 4 linked publications.
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 26 Aug 2021.