Non-contact Vital Signs Monitoring in Anesthesia

• Conditions: Vital Signs; Anesthesia; Monitors
• Interventions: Device: Non-contact vital signs monitoring with camera

• Registration Number: NCT05023356
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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.

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 Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26
• Study Start: 2021-09-10
• Primary Completion: 2021-10-31
• Study Completion: 2022-05-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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%).

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-contact vital signs monitoring	Non-contact vital signs monitoring with camera	Camera

Primary Outcome Measures

Name	Time	Method
Signal similarities	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.