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临床试验/NCT05947721
NCT05947721已完成不适用

Observational Study to Collect an Image Dataset of Healthy Population With a Characterization of the Potential Factors, Both Intrinsic (Age, BMI, Sex, Fitzpatrick Phototype, Risk Factors) and Extrinsic to the Subject (Distance and Illuminance), That May Influence the Methodologies Used to Obtain Vital Signs. The Aim is to Develop Algorithms and AI Models That Can Obtain a Set of Vital Signs Image-based. The Dataset Has Been Recorded Synchronized With the Main Vital Signs by Means Gold Standard Technologies.

Instituto de Biomecanica de Valencia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Oxigen saturation (SpO2)

研究概览

简要总结

The objective of this study is to collect an image dataset of healthy and pathological population with a characterization of the potential factors that may influence the methodologies used to obtain vital signs. To this end, an observational study of qualitative and quantitative data collection through cameras, contact recording technologies (gold standards) and questionnaires has been proposed.

Based on these data, the specific objectives of this study are as follows:

  • To determine the differences according to the factors analysed.
  • Develop/fine-tune algorithms/AI models to obtain quality rPPG/rBCG signals.
  • Fine-tune models to obtain the main vital signs as HR, RR, SpO2 and BP from image-based-data.

The dataset (namely Freyja/IBV-Dataset) is composed of 73 subjects (35 females and 38 males) with ages ranging from 18 to 85, representation in the 6 skin phototypes according to the Fitzpatrick scale (1), and BMI ranging from 15 to 40. In order to determine the sample size, specific ranges have been defined for each of the intrinsic subject factors and all possible combinations have been covered. The number of subjects defined for each combination was based on the percentage it represents in the Spanish population according to the INE (Instituto Nacional de Estadística).

The subjects will be recruited through the own databases of participants in previous trials of the Institute of Biomechanics of Valencia, who have given written consent to be contacted in order to request their participation in any other study where their profile may fit.

The surveys will be included in an online platform specialized in the realization of questionnaires. This data will be exported for further storage, management and analysis. All information will be anonymized for processing and analysis, and may be used under the terms and conditions dictated by the current legal framework.

To participate in the study, participants must accept the terms and conditions included in the first page of the survey embedded in the online platform, where the aspects related to the study methodology and the use of them data are exposed.

详细描述

5.2.1. SCIENTIFIC JUSTIFICATION OF THE PROJECT Vital signs monitoring is essential in modern clinical patient care both in hospital and at home. Some examples are heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2) or blood pressure (BP), which provide crucial information on the state of a human biological system (2). The recording of these signals is usually performed with traditional devices that require contact with the patient through elements such as surface electrodes, pulse oximeter, or piezoelectric transducers. These devices are unsuitable for long-term vital signs monitoring as they can cause discomfort, irritation and a cumulative risk of fungal and bacterial infections. Moreover, they can cause skin infections, wounds and harmful reactions on patients with fragile skin, such as premature babies, older people or burned patients (3). On the other hand, many of the materials used to monitor patients are only intended for a single use (such as electrodes and leads), and then must be disposed, which entails important costs (2).

The idea of recording of these signals without the need for direct skin contact is rising as an alternative able to eliminate potential medical complications and to solve usability issues related to the need for contact devices. New technologies aim to monitor multiple vital signs with a single device, at any time and in any place (4), which would allow the prevention of certain pathologies while improving patients' health. In addition, the costs associated with the acquisition of single-use sensors, as well as patients' hospitalisation, would be reduced.

Recently, there has been a notable development in the techniques for obtaining vital signs from non-contact technologies. These focus on the observation of physical and physiological variations of the human body due to the activity of the respiratory and cardiovascular systems. Notably, these variations include skin colour, temperature, impedance changes, head motion, arterial pulse motion, and thoracic and abdominal motion (2,5).

One of the most used technologies in the development of portable devices to monitor physiological signals is video camera imaging. This passive contactless method exploits two main principles (2). First, the colour of blood varies due to the exchange of gases through cardiorespiratory action, altering the optical properties of the skin. This can be described as photoplethysmography (PPG) (5). These variations in skin colour can be appreciated in sequences of images obtained with a video camera and be exploited to obtain a signal of remote PPG (rPPG), from which several vital signs can be measured. The second principle is based on the measurement of the ballistocardiogram (BCG), which depends on subtle cyclic head motions generated as a result of pressure changes from the influx of blood at each pulse (2,5).

Since video cameras do not need any kind of interaction with the patient, they represent a promising approach for contactless monitoring. Their main advantages are their robustness, reliability, safety, cost-effectiveness, and suitability for long distance and long-term monitoring.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women older tan 18 years old with no chronic or acute conditions declared.
  • Having the ability to understand the information of the questionnaires to be completed.

排除标准

  • Non-acceptance of the terms and conditions of the study.
  • Electronic implants (pacemakers, insulin pumps, cochlear implants).
  • Epilepsy.
  • Allergies or cutaneous hypersensitivity to the different components of the contact equipment, such as gels/adhesives.
  • Presence of tattoos or other serious skin alterations (large burns, keloids...) in the face area.
  • Infectious diseases of the skin, atopic dermatitis, erythroderma, rosacea...

结局指标

主要结局

Oxigen saturation (SpO2)

时间窗: Cross-sectional: Observations or measurements made at a single point in time, usually at subject enrollment.

SpO2 is the fraction of oxygen-saturated haemoglobin relative to total haemoglobin (unsaturated + saturated) in the blood.

General information questionnaire

时间窗: Cross-sectional: Observations or measurements made at a single point in time, usually at subject enrollment.

Custom-made questionnaire designed to collect relevant sociodemografic and clinical information os each subject, including: age, gender, height, weight, date of birth, Fitzpatrick Phototype and risk factors (hypertension, diabetes, tabacquismo, diet, apnea, physical activity, alcohol consumption and metabolic syndrome).

Heart Rate (HR)

时间窗: Cross-sectional: Observations or measurements made at a single point in time, usually at subject enrollment. Each of the registers have a duration of 60s.

Frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute).

Respiration Rate (RR)

时间窗: Cross-sectional: Observations or measurements made at a single point in time, usually at subject enrollment. Each of the registers have a duration of 60s.

The respiratory rate is the rate at wich breathing occurs and is measured in breaths per minute.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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