Children Clinical Trial
Official title:
Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
Verified date | October 2017 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study aims to assess the accuracy of the SpotOn™ Zero-heat-flux-thermometry sensor in measuring core temperature in the paediatric population in the perioperative period.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 1, 2018 |
Est. primary completion date | April 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility |
Inclusion Criteria: - ASA I & II - Age: 1d - 16 years - Elective surgery - Minimum anaesthesia time of 30 minutes Exclusion Criteria: - Fragile skin state in the forehead - Know allergy to probe adhesive - Maxillofacial trauma or lesions - Procedures impeding proper use of SpotOn™ sensor (mostly maxillo-facial) - Abnormal oesophageal anatomy/gastroesophageal procedures. - Coagulopathy - Neurologically impaired children with abnormal thermoregulation - Extensive Haemodynamic instability - Need for Vasopression - Procedures associated with extended use of rinsing fluids (abdominal/thoracic lavages) - Thoracoscopic/thoracotomic procedures (oesophageal probe cooling) - Need for use of "over body" forced air warming systems - Malignant Hyperthermia or family history of malignant hyperthermia - Fever / Infectious patient - All conditions that might be judged to alter skin perfusion in an abnormal way - Anatomical variants (overt hydrocephalus …) - Calibration/device failure |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Jette | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of accuracy of SpotOn in children | degrees centigrade | 2 hours |
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