- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571554
Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients
Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients: a Prospective Cohort Study
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.
Study Overview
Status
Conditions
Detailed Description
The enrolled patient will be sedated according to the ICU protocol. A calibrated esophageal thermometer will be inserted by the attending intensivist through the nostril or oral cavity into the lower third of the esophagus to approximately 10-20 cm.
IRT will be performed using FLIR C2 compact thermal camera. The focal length of the thermal camera will be adjusted at 0.5 meter from the patient head. scanning will conducted over a period of 10-seconds. The researcher will record the highest reading obtained from medial canthus. No cold fomentations will be applied to the head nor the axilla of the patient for 30 minutes at least before measuring IRT.
FLIR C2 thermal camera will be calibrated before use to eliminate the effect of the ambient room temperature.
The researcher of will obtain the IRT temperature will be blinded to the esophageal probe reading.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11562
- Kasr Alaini hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of IRT to detect fever (≥38.3⁰C).
Time Frame: from focusing the camera on the patients face for 10 seconds
|
Accuracy of IRT to detect fever (≥38.3⁰C)
measured by esophageal thermometer
|
from focusing the camera on the patients face for 10 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between IRT temperature readings and the simultaneous esophageal thermometer reading
Time Frame: from focusing the camera on the patients face for 10 seconds
|
degree Celsius
|
from focusing the camera on the patients face for 10 seconds
|
|
Bias and agreement in IRT temperature readings and the simultaneous esophageal thermometer reading
Time Frame: from focusing the camera on the patients face for 10 seconds
|
degree Celsius
|
from focusing the camera on the patients face for 10 seconds
|
|
Comparison the accuracy of IRT and axillary temperature in detecting fever
Time Frame: from focusing the camera on the patients face for 10 seconds
|
Accuracy to detect fever (≥38.3⁰C)
measured by esophageal thermometer
|
from focusing the camera on the patients face for 10 seconds
|
|
Comparison the accuracy of IRT and tympanic membrane temperature in detecting fever
Time Frame: from focusing the camera on the patients face for 10 seconds
|
Accuracy to detect fever (≥38.3⁰C)
measured by esophageal thermometer
|
from focusing the camera on the patients face for 10 seconds
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmed M Hasanin, M.D, Cairo University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-102-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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