Continuous Temperature Measurement by Thermal Imaging Camera

NCT06256978 | Not Yet Recruiting

• 1 other identifier: 23-63
• Study Type: observational
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Critically Ill

Keywords

Body temperature monitoring; Thermal Imaging Camera; Critical care; Fever; Temperature measurement methods; Intensive Care Units (ICUs)

Outcome Measures

Primary Outcomes (1)

• 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

  10 months

Secondary Outcomes (6)

• Sociodemographic and clinical characteristics of the study population.

  10 months

• Test validity for fever and hypothermia

  10 months

• Difference until fever detection

  10 months

• Thermal curve patterns

  10 months

• Thermal curve patterns in patients with infection upon admission and patients who develop infection during admission

  10 months

Study Arms (1)

Critical care patients

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• Patients from whom information from the thermal imaging camera cannot be obtained due to technical reasons.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• Fundación ASISA: collaborator

MeSH Terms

Conditions

Critical Illness; Fever

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Central Study Contacts

Samuel Gonzalez, Doctor

CONTACT

+34 917581196; samuel.gonzalez@grupohla.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share