Temperature MonitoringNCT04571554
Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients
An observational study of Temperature Monitoring, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temperature Monitoring
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill intubated adult patients (>18 years)
Who may be able to join
- Critically ill intubated adult patients (>18 years)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temperature Monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of IRT to detect fever (≥38.3⁰C).
Accuracy of IRT to detect fever (≥38.3⁰C) measured by esophageal thermometer
Measured: from focusing the camera on the patients face for 10 seconds
Secondary outcomes (4)
Correlation between IRT temperature readings and the simultaneous esophageal thermometer reading
degree Celsius
Measured: from focusing the camera on the patients face for 10 seconds
Bias and agreement in IRT temperature readings and the simultaneous esophageal thermometer reading
degree Celsius
Measured: from focusing the camera on the patients face for 10 seconds
Comparison the accuracy of IRT and axillary temperature in detecting fever
Accuracy to detect fever (≥38.3⁰C) measured by esophageal thermometer
Measured: from focusing the camera on the patients face for 10 seconds
Comparison the accuracy of IRT and tympanic membrane temperature in detecting fever
Accuracy to detect fever (≥38.3⁰C) measured by esophageal thermometer
Measured: from focusing the camera on the patients face for 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
- Investigators
- Ahmed M Hasanin, M.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571554
- Sponsor's protocol ID
- MS-102-2020
- Status last verified
- Feb 2021
- First submitted
- 26 Sep 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04571554
- Acronym / sponsor ID
- MS-102-2020
- Conditions
- Temperature Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Oct 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill intubated adult patients (>18 years)
Key inclusion criteria (1 listed)
- Critically ill intubated adult patients (>18 years)
Key exclusion criteria (3 listed)
- 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.
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
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
4 secondary outcomes
Correlation between IRT temperature readings and the simultaneous esophageal thermometer reading
Time frame: 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
Comparison the accuracy of IRT and axillary temperature in detecting fever
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed M Hasanin, M.D study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Monitoring, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of IRT to detect fever (≥38.3⁰C). (time frame: from focusing the camera on the patients face for 10 seconds). 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 23 Feb 2021.