Temperature Monitoring Clinical Trial
Official title:
Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients: a Prospective Cohort Study
NCT number | NCT04571554 |
Other study ID # | MS-102-2020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | January 1, 2021 |
Verified date | February 2021 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Accurate determination of critically ill patient of being febrile or not is an essential part of management critically ill patients as it prompt investigating the underlying cause and initiating therapeutic action. Pulmonary artery catheter thermistor is considered the gold standard for temperature measurement . Central non-vascular thermometer such as esophageal, bladder and rectal thermometer showed excellent correlation and agreement with pulmonary artery catheter thermistor and has been accepted as alternative methods for core body temperature assessment. However, those methods are invasive and cannot be tolerated in conscious patients. Peripheral thermometer such as oral, axillary and tympanic membrane thermometer are either impractical in unconscious patient and/or carry the risk of trauma and infection. Infrared thermography (IRT) is a non-contact and non-invasive imaging approach that enable real-time estimation of body temperature by detecting infrared emission. IRT had been used for screening for mass detection of febrile patients at airport at times of infectious disease outbreak. In adult population, IRT showed good accuracy in detecting febrile patients in emergency department; however, those studies used 37.7⁰ C as the fever threshold and the reference standard was either oral 6 or tympanic membrane thermometer. No studies to the best of our knowledge had evaluated the IRT accuracy in detecting fever in critically ill patients using esophageal thermometer as a reference method.
Status | Completed |
Enrollment | 135 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Critically ill intubated adult patients (>18 years) Exclusion Criteria: - Patients with condition that preclude the application of esophageal thermometer such as esophageal varices, diverticulum, stenosis and malignancy - patients with eye pathology as inflammation or malignancy which would interfere with the interpretation of the IRT reading, - Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alaini Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of IRT to detect fever (=38.3°C). | Accuracy of IRT to detect fever (=38.3°C) measured by esophageal thermometer | from focusing the camera on the patients face for 10 seconds | |
Secondary | Correlation between IRT temperature readings and the simultaneous esophageal thermometer reading | degree Celsius | from focusing the camera on the patients face for 10 seconds | |
Secondary | Bias and agreement in IRT temperature readings and the simultaneous esophageal thermometer reading | degree Celsius | from focusing the camera on the patients face for 10 seconds | |
Secondary | Comparison the accuracy of IRT and axillary temperature in detecting fever | Accuracy to detect fever (=38.3°C) measured by esophageal thermometer | from focusing the camera on the patients face for 10 seconds | |
Secondary | Comparison the accuracy of IRT and tympanic membrane temperature in detecting fever | Accuracy to detect fever (=38.3°C) measured by esophageal thermometer | from focusing the camera on the patients face for 10 seconds |
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