Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947721
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-07-07
Brief Title:
High-quality Image NIR and RGB Dataset Synchronized With Contact Vital Sings Recordings and Clinical Data of Stratified Healthy Population Algorithms and AI Models to Obtain a Set of Vital Signs Image-based
Sponsor:
Instituto de Biomecanica de Valencia
Organization:
Instituto de Biomecanica de Valencia
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREJYAIBV
Brief Summary:
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
Developfine-tune algorithmsAI models to obtain quality rPPGrBCG signals
Fine-tune models to obtain the main vital signs as HR RR SpO2 and BP from image-based-data
The dataset namely FreyjaIBV-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 EstadÃstica
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
Based on these data the specific objectives of this study are as follows
To determine the differences according to the factors analysed
Developfine-tune algorithmsAI models to obtain quality rPPGrBCG signals
Fine-tune models to obtain the main vital signs as HR RR SpO2 and BP from image-based-data
The dataset namely FreyjaIBV-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 EstadÃstica
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
Detailed Description:
521 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 25
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 25
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
Having a database that includes the main important factors to calculate vital signs from image-camera will allow both the development of specific and more accurate algorithms and the training of AI-based models to obtain vital signs using image-based technology
In this context it should be added that the Institute of Biomechanics of Valencia has worked on a large number of projects both national and European having extensive experience in the signal processing and analysis of physiological signals
SuaaVE httpswwwsuaaveeu
Senserror httpswwwibvorgproyectosenserror-modelizacin-y-evaluacin-del-error-humano-mediante-procesos-cognitivos
SOLFIS httpswwwibvorgproyectosolfis-soluciones-aplicadas-basadas-en-medidas-fisiologicas
imc2 httpswwwibvorgproyectoemc2incorporacin-de-los-modelos-emocionales-y-cognitivos-en-el-sector-del-transp 522 PROJECT OBJECTIVES LONG-TERM GOAL 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
Having a database that includes the main important factors to calculate vital signs from image-camera will allow both the development of specific and more accurate algorithms and the training of AI-based models to obtain vital signs using image-based technology
Based on these data the specific objectives of this study are as follows
To determine the differences according to the factors analysed
Developfine-tune algorithmsAI models to obtain quality rPPGrBCG signals
Developfine-tune algorithmsAI models to obtain the main vital signs as HR RR SpO2 and BP from image-based-data
523 METHODOLOGY TYPE OF STUDY 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
STUDY SAMPLE Sample size At least 60 subjects that cover all the specific ranges defined for each of the intrinsic subject factors age BMI sex and Fitzpatrick phototype The number of subjects defined for each combination was based on the percentage it represents in the Spanish population
The sample it has been strata based on gender Fitspatrick Phototype BMI and age with the following ranges
Sex female F and male M
Fitzpatrick Phptotype I-II F1 III-IV F2 and V-VI F3
BMI 21 B1 21 BMI29 B2 and 29 B3
Age 50 A1 and 50 A2
Based on the defined ranges it has been obtained 36 subgroups with the following characteristics
G1 FF1B1A1
G2 FF1B1A2
G3 FF1B2A1
G4 FF1B2A2
G5 FF1B3A1
G6 FF1B3A2
G7 FF2B1A1
G8 FF2B1A2
G9 FF2B2A1
G10 FF2B2A2
G11 FF2B3A1
G12 FF2B3A2
G13 FF3B1A1
G14 FF3B1A2
G15 FF3B2A1
G16 FF3B2A2
G17 FF3B3A1
G18 FF3B3A2
G19 MF1B1A1
G20 MF1B1A2
G21 MF1B2A1
G22 MF1B2A2
G23 MF1B3A1
G24 MF1B3A2
G25 MF2B1A1
G26 MF2B1A2
G27 MF2B2A1
G28 MF2B2A2
G29 MF2B3A1
G30 MF2B3A2
G31 MF3B1A1
G32 MF3B1A2
G33 MF3B2A1
G34 MF3B2A2
G35 MF3B3A1
G36 MF3B3A2 MEASUREMENT TOOLS
The measurement equipment used to register has been
RR register biosignalsplux tool-kit with Respiration PZT sensor data To acquire the raw data OpenSignals revolution software have been used
HR register biosignalsplux tool-kit with electrocardiography ECG sensor data To acquire the raw data OpenSignals revolution software have been used
SpO2 register biosignalsplux tool-kit with blood volume pulse BVP finger clip sensor data To acquire the raw data OpenSignals revolution software have been used
BP register Withings BPM Connect WPM05 digital sphygmomanometer
Sync register biosignalsplux synchronization SYNC accessory data To acquire the raw data OpenSignals revolution software have been used
Images register FLIR GS3-U3-41C6C and FLIR GS3-U3-41C6NIR cameras All the biosignalsplux sensors have been synchronized with cameras thought the SYNC accessory
On the other hand a questionnaire designed by the IBV on clinical factors was completed The questionnaire is described in detail in section 9
All the recordings have been carried out by IBV qualified staff to perform the tests and have been performed in the IBV facilities specifically in the Living Lab laboratory with climate and lighting control to adapt the test conditions
MEASUREMENT PROTOCOL Potential participants will initially be contacted by the corresponding key entity or agent collaborators specified in the corresponding section 3 SponsorCollaborators including the IBV itself through the databases of previous trials The IBV will contact those users interested in participating who meet the inclusion criteria and who give their consent to be contacted
Two sessions were carried out at different times of the day for each of the subjects In the first one 9 am to 12 am 4 measurements were taken modifying the distance between the subject and the equipment 1 m and 2 m and the entrance of natural light presence or absence of natural light In the second session 4 pm to 530 pm only one measurement was taken at 1 m with natural light aiming to record pressure at its maximum peak of the day The subject remained seated and instrumented throughout the sessions The forehead face and lower neck were exposed to the cameras Prior to each measurement the ambient light condition was recorded using a luxmeter Subjects were required to remain still and quiet breathing normally They also had to raise their hands to the level of their heads with the right palm facing forward At the beginning and at the end of each recording systolic and diastolic blood pressure were measured with the Withings BPM Connect WPM05 digital sphygmomanometer
Each recording lasted 80s during the first 20s the scene was illuminated with a pulsed light and in the following 60s a constant light was used
VARIABLES ANALYZED The variables analysed correspond to the data collected in each sensor data and questionnaires All the variables are described in section 9 Outcome Measures
STATISTICAL ANALYSIS
A statistical analysis will be carried out that will serve to respond to the objectives of the study The statistical analysis will treat the data provided by the parameters obtained with the reference measurement techique compared with the parameters obtained with the algorithmsAI models developed To do this the following statistics will be used
Pearsons Correaltion coefficient linear correlation between two sets of data It is the ratio between the covariance of two variables and the product of their standard deviations
Cronbachs alpha reliability coefficient and measure of internal consistency os tests and measures
Accuracy value of how close given set of measurements are to their true value Depending on the type of algorithmsAI models implemented the statistics may be different
DATA MANAGEMENT AND PROCESSING A user code will be assigned to each participant so that the questionnaires can be linked while maintaining the anonymity of the participants for the IBV This code will be the one provided to identify yourself in the online questionnaire or the one that will be added to the questionnaire that is completed by telephone if applicable
All information will be anonymized for processing and analysis and may be used under the terms and conditions dictated by the current legal framework
Once the project is finished the data obtained will be stored always in an anonymized form and under the legal custody of the IBV The subsequent use and retention period of the data are governed as contemplated in the informed consent documents with respect to current legislation
The acceptance of the written document of Informed Consent is made through checkboxes at the beginning of the online survey itself In the case of patients who are surveyed by telephone the document corresponding to Written Informed Consent will be sent before the interview and subsequently they will be asked for consent verbally after ensuring that they have reviewed and understood the conditions of their participation in the study
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 25
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 25
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
Having a database that includes the main important factors to calculate vital signs from image-camera will allow both the development of specific and more accurate algorithms and the training of AI-based models to obtain vital signs using image-based technology
In this context it should be added that the Institute of Biomechanics of Valencia has worked on a large number of projects both national and European having extensive experience in the signal processing and analysis of physiological signals
SuaaVE httpswwwsuaaveeu
Senserror httpswwwibvorgproyectosenserror-modelizacin-y-evaluacin-del-error-humano-mediante-procesos-cognitivos
SOLFIS httpswwwibvorgproyectosolfis-soluciones-aplicadas-basadas-en-medidas-fisiologicas
imc2 httpswwwibvorgproyectoemc2incorporacin-de-los-modelos-emocionales-y-cognitivos-en-el-sector-del-transp 522 PROJECT OBJECTIVES LONG-TERM GOAL 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
Having a database that includes the main important factors to calculate vital signs from image-camera will allow both the development of specific and more accurate algorithms and the training of AI-based models to obtain vital signs using image-based technology
Based on these data the specific objectives of this study are as follows
To determine the differences according to the factors analysed
Developfine-tune algorithmsAI models to obtain quality rPPGrBCG signals
Developfine-tune algorithmsAI models to obtain the main vital signs as HR RR SpO2 and BP from image-based-data
523 METHODOLOGY TYPE OF STUDY 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
STUDY SAMPLE Sample size At least 60 subjects that cover all the specific ranges defined for each of the intrinsic subject factors age BMI sex and Fitzpatrick phototype The number of subjects defined for each combination was based on the percentage it represents in the Spanish population
The sample it has been strata based on gender Fitspatrick Phototype BMI and age with the following ranges
Sex female F and male M
Fitzpatrick Phptotype I-II F1 III-IV F2 and V-VI F3
BMI 21 B1 21 BMI29 B2 and 29 B3
Age 50 A1 and 50 A2
Based on the defined ranges it has been obtained 36 subgroups with the following characteristics
G1 FF1B1A1
G2 FF1B1A2
G3 FF1B2A1
G4 FF1B2A2
G5 FF1B3A1
G6 FF1B3A2
G7 FF2B1A1
G8 FF2B1A2
G9 FF2B2A1
G10 FF2B2A2
G11 FF2B3A1
G12 FF2B3A2
G13 FF3B1A1
G14 FF3B1A2
G15 FF3B2A1
G16 FF3B2A2
G17 FF3B3A1
G18 FF3B3A2
G19 MF1B1A1
G20 MF1B1A2
G21 MF1B2A1
G22 MF1B2A2
G23 MF1B3A1
G24 MF1B3A2
G25 MF2B1A1
G26 MF2B1A2
G27 MF2B2A1
G28 MF2B2A2
G29 MF2B3A1
G30 MF2B3A2
G31 MF3B1A1
G32 MF3B1A2
G33 MF3B2A1
G34 MF3B2A2
G35 MF3B3A1
G36 MF3B3A2 MEASUREMENT TOOLS
The measurement equipment used to register has been
RR register biosignalsplux tool-kit with Respiration PZT sensor data To acquire the raw data OpenSignals revolution software have been used
HR register biosignalsplux tool-kit with electrocardiography ECG sensor data To acquire the raw data OpenSignals revolution software have been used
SpO2 register biosignalsplux tool-kit with blood volume pulse BVP finger clip sensor data To acquire the raw data OpenSignals revolution software have been used
BP register Withings BPM Connect WPM05 digital sphygmomanometer
Sync register biosignalsplux synchronization SYNC accessory data To acquire the raw data OpenSignals revolution software have been used
Images register FLIR GS3-U3-41C6C and FLIR GS3-U3-41C6NIR cameras All the biosignalsplux sensors have been synchronized with cameras thought the SYNC accessory
On the other hand a questionnaire designed by the IBV on clinical factors was completed The questionnaire is described in detail in section 9
All the recordings have been carried out by IBV qualified staff to perform the tests and have been performed in the IBV facilities specifically in the Living Lab laboratory with climate and lighting control to adapt the test conditions
MEASUREMENT PROTOCOL Potential participants will initially be contacted by the corresponding key entity or agent collaborators specified in the corresponding section 3 SponsorCollaborators including the IBV itself through the databases of previous trials The IBV will contact those users interested in participating who meet the inclusion criteria and who give their consent to be contacted
Two sessions were carried out at different times of the day for each of the subjects In the first one 9 am to 12 am 4 measurements were taken modifying the distance between the subject and the equipment 1 m and 2 m and the entrance of natural light presence or absence of natural light In the second session 4 pm to 530 pm only one measurement was taken at 1 m with natural light aiming to record pressure at its maximum peak of the day The subject remained seated and instrumented throughout the sessions The forehead face and lower neck were exposed to the cameras Prior to each measurement the ambient light condition was recorded using a luxmeter Subjects were required to remain still and quiet breathing normally They also had to raise their hands to the level of their heads with the right palm facing forward At the beginning and at the end of each recording systolic and diastolic blood pressure were measured with the Withings BPM Connect WPM05 digital sphygmomanometer
Each recording lasted 80s during the first 20s the scene was illuminated with a pulsed light and in the following 60s a constant light was used
VARIABLES ANALYZED The variables analysed correspond to the data collected in each sensor data and questionnaires All the variables are described in section 9 Outcome Measures
STATISTICAL ANALYSIS
A statistical analysis will be carried out that will serve to respond to the objectives of the study The statistical analysis will treat the data provided by the parameters obtained with the reference measurement techique compared with the parameters obtained with the algorithmsAI models developed To do this the following statistics will be used
Pearsons Correaltion coefficient linear correlation between two sets of data It is the ratio between the covariance of two variables and the product of their standard deviations
Cronbachs alpha reliability coefficient and measure of internal consistency os tests and measures
Accuracy value of how close given set of measurements are to their true value Depending on the type of algorithmsAI models implemented the statistics may be different
DATA MANAGEMENT AND PROCESSING A user code will be assigned to each participant so that the questionnaires can be linked while maintaining the anonymity of the participants for the IBV This code will be the one provided to identify yourself in the online questionnaire or the one that will be added to the questionnaire that is completed by telephone if applicable
All information will be anonymized for processing and analysis and may be used under the terms and conditions dictated by the current legal framework
Once the project is finished the data obtained will be stored always in an anonymized form and under the legal custody of the IBV The subsequent use and retention period of the data are governed as contemplated in the informed consent documents with respect to current legislation
The acceptance of the written document of Informed Consent is made through checkboxes at the beginning of the online survey itself In the case of patients who are surveyed by telephone the document corresponding to Written Informed Consent will be sent before the interview and subsequently they will be asked for consent verbally after ensuring that they have reviewed and understood the conditions of their participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None