Critically IllTermoCamUCINCT06256978
Continuous Temperature Measurement by Thermal Imaging Camera
An observational study of Critically Ill, run by Universidad Europea de Madrid.
Trial summary
This study explores the significance of body temperature monitoring in hospitalized patients, particularly in critical care environments. With body temperature exhibiting considerable variability, fever, defined at a central temperature of 38.3°C, serves as a pertinent indicator across diverse medical conditions. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Critically Ill
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jan 2025
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted on all patients admitted to the ICU rooms at HLA Moncloa University Hospital, equipped with an infrared camera for continuous measurement of skin temperature
Who may be able to join
- Patients admitted to the ICU in a room with a thermal imaging camera
- Patients who provide voluntary consent to participate in the study (Annex 2). If the participant is not in full physical or intellectual capacity to provide their signature in the informed consent, the responsible investigator will seek consent from their direct family member or the legally designated person to make decisions on their behalf regarding health matters. This measure is adopted to ensure the participant's rights are respected and the integrity of the consent process is maintained, even in situations where their decision-making capacity may be compromised.
Who cannot join
- Patients from whom information from the thermal imaging camera cannot be obtained due to technical reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Continuous Temperature Measurement by Thermal Imaging Camera: Concordance, Patterns, and Intelligent Prediction of Events in Critical Patients
This study explores the significance of body temperature monitoring in hospitalized patients, particularly in critical care environments. With body temperature exhibiting considerable variability, fever, defined at a central temperature of 38.3°C, serves as a pertinent indicator across diverse medical conditions. Temperature measurement methods in Intensive Care Units (ICUs) range from routine peripheral measurements to more invasive central temperature monitoring.
Critical patients with fever often receive antibiotic treatment, even without conclusive evidence of infection, as early intervention is linked to improved survival in septic patients. However, the complexity of individual variability, circadian rhythms, medication effects, and methodological limitations underscores the impracticality of defining fever with a singular temperature value. The thermal curve, representing the temporal evolution of temperature, emerges as a nuanced parameter in this context.
Read more
This study seeks to establish the correlation between axillary temperature measurements, a conventional method, and temperatures recorded by thermal imaging cameras. Widely employed during the Covid-19 pandemic, these cameras offer non-invasive and contactless measurement, mitigating pathogen transmission risks, particularly in patients colonized by multidrug-resistant microorganisms or those with compromised skin integrity. The study also endeavors to evaluate the diagnostic validity of thermal imaging cameras for fever and hypothermia.
The integration of thermal imaging cameras into a system capable of automated, real-time peripheral temperature acquisition suggests a potential paradigm shift in ICU temperature monitoring practices. Beyond immediate clinical applications, the amassed data from this system holds promise for training intelligent systems through machine learning algorithms. This strategic integration aims to predict critical events, such as the onset of fever, nosocomial infections, or shock, marking a forward-looking approach to patient management.
Read the detailed description
This study delves into the nuanced domain of body temperature monitoring in the context of hospitalized patients, with a particular emphasis on critical care settings. The primary physiological variable under scrutiny is body temperature, a parameter that has been extensively examined in the clinical realm. It is underscored that the normal range for body temperature hovers around 36.7°C, but with a significant degree of variability spanning from 35.3 to 37.7°C, both among different individuals and within the same person throughout the day.
Fever, a crucial clinical manifestation, is operationally defined by a consensus reached by the American College of Critical Care Medicine and the Infectious Diseases Society of America, placing it at a central temperature of 38.3°C. This central temperature refers to the temperature of internal organs, and the thermal elevation associated with fever is not exclusive to infectious processes but extends to various other conditions, including autoimmune diseases, oncological conditions, bleeding, inflammatory reactions, surgical procedures, and drug-induced scenarios.
The multifaceted landscape of temperature measurement methods in Intensive Care Units (ICUs) is acknowledged, with peripheral temperature measurements using contact thermometers in the axilla being the most common approach. For patients with sustained fever or those undergoing therapeutic hypothermia, continuous monitoring of central temperature through various methods such as rectal, tympanic, vesical, or esophageal measurements is considered. However, the more invasive nature of central temperature monitoring, coupled with technical challenges, higher economic costs, and potential complications, limits its widespread utilization.
The critical nature of thermal monitoring in the care of patients is highlighted, especially considering that fever often prompts antibiotic treatment, even in the absence of confirmed infection, due to the observed improvement in survival rates among septic patients with early intervention. The complex landscape surrounding temperature measurement, characterized by individual variability, circadian changes, diverse measurement methods, medication influence, and methodological deficiencies, prompts a reconsideration of the feasibility of defining fever based on a single temperature value. To address this complexity, the study introduces the concept of the thermal curve, representing the temporal evolution of temperature throughout the day, which may exhibit sustained elevation or peaks and may or may not respond to interventions like antipyretics, antibiotics, or other temperature control methods.
An additional challenge in fever monitoring, particularly with sporadic measurements rather than continuous monitoring, is the potential oversight of febrile peaks or the failure to capture the maximum or minimum temperature values experienced by the patient. This limitation underscores the need for innovative approaches to temperature monitoring that can overcome these challenges.
As a pioneering step, the primary objective of the study is outlined: to establish the concordance between axillary temperature measurements (a widely used method) and temperatures recorded by a thermal imaging camera at the same moments. Thermal imaging cameras, which have gained prominence during the Covid-19 pandemic for fever screening in healthcare settings and other facilities, are proposed for use in hospitalized patients. The advantages of thermal imaging cameras are expounded upon, including non-invasive and contactless measurement, which reduces the risk of pathogen transmission, especially in patients colonized by multidrug-resistant microorganisms. Furthermore, these cameras facilitate temperature measurement in patients with compromised skin integrity. The automated and continuous acquisition of temperature data provided by thermal imaging cameras is positioned as a potential game-changer, offering valuable information for patient management without imposing an additional burden on healthcare professionals. In fact, it is suggested that such automated systems may even reduce the nursing and auxiliary workload, enhancing overall efficiency in patient care.
Despite the potential advantages, the study acknowledges the existing challenges and limitations associated with thermal imaging cameras. The lack of diagnostic test validity studies for most thermal imaging cameras and contradictory results in published studies have led to their limited adoption in hospital environments. However, recent systematic reviews emphasize the considerable potential of these cameras, pending further validation studies.
Within the ambit of secondary objectives, the study aims to assess the validity of thermal imaging cameras as a diagnostic test for fever and hypothermia. This evaluation is crucial for determining the reliability and accuracy of thermal imaging cameras in a clinical context.
The discussion further extrapolates the potential transformative impact of integrating thermal imaging cameras into a system capable of automated and real-time peripheral temperature acquisition. This integration is posited as a potential paradigm shift in standard temperature monitoring practices within ICUs. Beyond the immediate clinical applications, the study suggests that the wealth of data generated by such a system could be utilized to train intelligent systems through machine learning algorithms. The overarching goal is to develop predictive models for critical events such as the onset of fever, nosocomial infections, or shock.
In summary, this study presents a comprehensive exploration of the complexities associated with body temperature monitoring in hospitalized patients, with a specific focus on critical care scenarios. The integration of thermal imaging cameras, while posing challenges, holds substantial promise for enhancing the precision and efficiency of temperature monitoring, thereby potentially revolutionizing patient care practices in ICUs.
- Conditions
- Critically Ill
- Keywords
- Body temperature monitoring, Thermal Imaging Camera, Critical care, Fever, Temperature measurement methods, Intensive Care Units (ICUs)
- Medical subject headings
- Critical Illness, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critical care patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between thermal imaging camera and axillary contact thermometer
To assess the concordance of temperature obtained continuously by a thermal imaging camera with that obtained by an axillary contact thermometer
Measured: 10 months
Secondary outcomes (6)
Sociodemographic and clinical characteristics of the study population.
To describe the sociodemographic (age and gender) and clinical characteristics (HTN, DM, DL, reason for ICU admission, SAPS3) of the study population.
Measured: 10 months
Test validity for fever and hypothermia
To study the diagnostic test validity of the thermal imaging camera for fever and hypothermia. Fever is defined as an axillary temperature of ≥ 37.5°C, and hypothermia is defined as an axillary temperature < 34.2°C
Measured: 10 months
Difference until fever detection
To determine the time difference until fever detection between the SF-HANDHELD-80TA05 thermal imaging camera or similar, and temperature measurement through the usual nursing practice following standard protocols in critical patients
Measured: 10 months
Thermal curve patterns
To describe the continuous thermal curve patterns taken by the thermal imaging camera in patients with the following pathologies: altered level of consciousness, acute coronary syndrome, cardiac rhythm disturbances, cardiac arrest, heart failure/cardiogenic shock, hypovolemic shock, sepsis/septic shock, shock of other etiology, respiratory failure, renal failure, metabolic disorders, intoxications, trauma, postoperative monitoring and surveillance, non-surgical procedure monitoring and surveillance, and others. Thermal curves will be obtained in at least 20 patients per pathology
Measured: 10 months
Thermal curve patterns in patients with infection upon admission and patients who develop infection during admission
To describe the continuous thermal curve patterns taken by the thermal imaging camera in patients with infectious complications in two cases: patients with infection upon admission and patients who develop infection during admission. Thermal curves will be obtained in at least 20 patients in each case.
Measured: 10 months
Regional thermal measurement
- To determine the adequacy of regional thermal measurement by reviewing the complete thermal image obtained by the SF-HANDHELD-80TA05 or similar camera
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación ASISA
- Responsible party
- Principal investigator, Samuel Gonzalez Lopez, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256978
- Sponsor's protocol ID
- 23-63
- Acronym
- TermoCamUCI
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Temperature Measurement by Thermal Imaging Camera: Concordance, Patterns, and Intelligent Prediction of Events in Critical Patients
- ClinicalTrials.gov ID
- NCT06256978
- Acronym / sponsor ID
- TermoCamUCI / 23-63
- Conditions
- Critically Ill
- Keywords
- Body temperature monitoring, Thermal Imaging Camera, Critical care, Fever, Temperature measurement methods, Intensive Care Units (ICUs)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Fundación ASISA
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Feb 2024 (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.
This study explores the significance of body temperature monitoring in hospitalized patients, particularly in critical care environments. With body temperature exhibiting considerable variability, fever, defined at a central temperature of 38.3°C, serves as a pertinent indicator across diverse medical conditions. Temperature measurement methods in Intensive Care Units (ICUs) range from routine peripheral measurements to more invasive central temperature monitoring.
Critical patients with fever often receive antibiotic treatment, even without conclusive evidence of infection, as early intervention is linked to improved survival in septic patients. However, the complexity of individual variability, circadian rhythms, medication effects, and methodological limitations underscores the impracticality of defining fever with a singular temperature value. The thermal curve, representing the temporal evolution of temperature, emerges as a nuanced parameter in this context.
This study seeks to establish the correlation between axillary temperature measurements, a conventional method, and temperatures recorded by thermal imaging cameras. Widely employed during the Covid-19 pandemic, these cameras offer non-invasive and contactless measurement, mitigating pathogen transmission risks, particularly in patients colonized by multidrug-resistant microorganisms or those with compromised skin integrity. The study also endeavors to evaluate the diagnostic validity of thermal imaging cameras for fever and hypothermia.
The integration of thermal imaging cameras into a system capable of automated, real-time peripheral temperature acquisition suggests a potential paradigm shift in ICU temperature monitoring practices. Beyond immediate clinical applications, the amassed data from this system holds promise for training intelligent systems through machine learning algorithms. This strategic integration aims to predict critical events, such as the onset of fever, nosocomial infections, or shock, marking a forward-looking approach to patient management.
Detailed description
This study delves into the nuanced domain of body temperature monitoring in the context of hospitalized patients, with a particular emphasis on critical care settings. The primary physiological variable under scrutiny is body temperature, a parameter that has been extensively examined in the clinical realm. It is underscored that the normal range for body temperature hovers around 36.7°C, but with a significant degree of variability spanning from 35.3 to 37.7°C, both among different individuals and within the same person throughout the day.
Fever, a crucial clinical manifestation, is operationally defined by a consensus reached by the American College of Critical Care Medicine and the Infectious Diseases Society of America, placing it at a central temperature of 38.3°C. This central temperature refers to the temperature of internal organs, and the thermal elevation associated with fever is not exclusive to infectious processes but extends to various other conditions, including autoimmune diseases, oncological conditions, bleeding, inflammatory reactions, surgical procedures, and drug-induced scenarios.
The multifaceted landscape of temperature measurement methods in Intensive Care Units (ICUs) is acknowledged, with peripheral temperature measurements using contact thermometers in the axilla being the most common approach. For patients with sustained fever or those undergoing therapeutic hypothermia, continuous monitoring of central temperature through various methods such as rectal, tympanic, vesical, or esophageal measurements is considered. However, the more invasive nature of central temperature monitoring, coupled with technical challenges, higher economic costs, and potential complications, limits its widespread utilization.
The critical nature of thermal monitoring in the care of patients is highlighted, especially considering that fever often prompts antibiotic treatment, even in the absence of confirmed infection, due to the observed improvement in survival rates among septic patients with early intervention. The complex landscape surrounding temperature measurement, characterized by individual variability, circadian changes, diverse measurement methods, medication influence, and methodological deficiencies, prompts a reconsideration of the feasibility of defining fever based on a single temperature value. To address this complexity, the study introduces the concept of the thermal curve, representing the temporal evolution of temperature throughout the day, which may exhibit sustained elevation or peaks and may or may not respond to interventions like antipyretics, antibiotics, or other temperature control methods.
An additional challenge in fever monitoring, particularly with sporadic measurements rather than continuous monitoring, is the potential oversight of febrile peaks or the failure to capture the maximum or minimum temperature values experienced by the patient. This limitation underscores the need for innovative approaches to temperature monitoring that can overcome these challenges.
As a pioneering step, the primary objective of the study is outlined: to establish the concordance between axillary temperature measurements (a widely used method) and temperatures recorded by a thermal imaging camera at the same moments. Thermal imaging cameras, which have gained prominence during the Covid-19 pandemic for fever screening in healthcare settings and other facilities, are proposed for use in hospitalized patients. The advantages of thermal imaging cameras are expounded upon, including non-invasive and contactless measurement, which reduces the risk of pathogen transmission, especially in patients colonized by multidrug-resistant microorganisms. Furthermore, these cameras facilitate temperature measurement in patients with compromised skin integrity. The automated and continuous acquisition of temperature data provided by thermal imaging cameras is positioned as a potential game-changer, offering valuable information for patient management without imposing an additional burden on healthcare professionals. In fact, it is suggested that such automated systems may even reduce the nursing and auxiliary workload, enhancing overall efficiency in patient care.
Despite the potential advantages, the study acknowledges the existing challenges and limitations associated with thermal imaging cameras. The lack of diagnostic test validity studies for most thermal imaging cameras and contradictory results in published studies have led to their limited adoption in hospital environments. However, recent systematic reviews emphasize the considerable potential of these cameras, pending further validation studies.
Within the ambit of secondary objectives, the study aims to assess the validity of thermal imaging cameras as a diagnostic test for fever and hypothermia. This evaluation is crucial for determining the reliability and accuracy of thermal imaging cameras in a clinical context.
The discussion further extrapolates the potential transformative impact of integrating thermal imaging cameras into a system capable of automated and real-time peripheral temperature acquisition. This integration is posited as a potential paradigm shift in standard temperature monitoring practices within ICUs. Beyond the immediate clinical applications, the study suggests that the wealth of data generated by such a system could be utilized to train intelligent systems through machine learning algorithms. The overarching goal is to develop predictive models for critical events such as the onset of fever, nosocomial infections, or shock.
In summary, this study presents a comprehensive exploration of the complexities associated with body temperature monitoring in hospitalized patients, with a specific focus on critical care scenarios. The integration of thermal imaging cameras, while posing challenges, holds substantial promise for enhancing the precision and efficiency of temperature monitoring, thereby potentially revolutionizing patient care practices in ICUs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical care patients | – | – |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on all patients admitted to the ICU rooms at HLA Moncloa University Hospital, equipped with an infrared camera for continuous measurement of skin temperature
Key inclusion criteria (2 listed)
- Patients admitted to the ICU in a room with a thermal imaging camera
- Patients who provide voluntary consent to participate in the study (Annex 2). If the participant is not in full physical or intellectual capacity to provide their signature in the informed consent, the responsible investigator will seek consent from their direct family member or the legally designated person to make decisions on their behalf regarding health matters. This measure is adopted to ensure the participant's rights are respected and the integrity of the consent process is maintained, even in situations where their decision-making capacity may be compromised.
Key exclusion criteria (1 listed)
- Patients from whom information from the thermal imaging camera cannot be obtained due to technical reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance between thermal imaging camera and axillary contact thermometer
Time frame: 10 months
To assess the concordance of temperature obtained continuously by a thermal imaging camera with that obtained by an axillary contact thermometer
6 secondary outcomes
Sociodemographic and clinical characteristics of the study population.
Time frame: 10 months
Test validity for fever and hypothermia
Time frame: 10 months
Difference until fever detection
Time frame: 10 months
Thermal curve patterns
Time frame: 10 months
Thermal curve patterns in patients with infection upon admission and patients who develop infection during admission
Time frame: 10 months
Regional thermal measurement
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Universidad Europea de Madrid.
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 1 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 13 Feb 2024. 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 Samuel Gonzalez, Doctor (+34 917581196, samuel.gonzalez@grupohla.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between thermal imaging camera and axillary contact thermometer (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.