Study on the Incidence of Perioperative Hypothermia at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell (PREVINQ-WARM)
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|ClinicalTrials.gov Identifier: NCT03961620|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment|
|Hypothermia||Device: The SpotOn system that encompasses the registration unit (3M SpotOn Control Unit), disposable sensor (3M SpotOn Control Sensor) along with the cords and electric power unit.|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||Prospective Observational Study on the Incidence of Perioperative Hypothermia and the Effect of Standard Normothermia Measures at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell: Tauli-Previnq-Warm|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2021|
- Device: The SpotOn system that encompasses the registration unit (3M SpotOn Control Unit), disposable sensor (3M SpotOn Control Sensor) along with the cords and electric power unit.
Patients submitted to major surgical procedure will be assessed for core body temperature by employing SpotOn sensor device, before, during and after surgical procedure.
- Rate of perioperative hypothermia (<36ºC) [ Time Frame: 12 hours ]Body temperature measured by SpotOn system sensor in different surgical procedures and at any specific surgical area.
- Type and duration of applied physical measures to prevent periopertive hypothermia [ Time Frame: 12 hours ]The investigators will corroborate whether or not textile blankets, forced air warming blankets or additional measures are applied, anf if so, the time and durations of such measures.
- Temperature at the operating room [ Time Frame: 1-6 hours ]Temperature and degree of humidity at the OR
- Thermal confort [ Time Frame: 1-6 hours ]Thermal comfort of patients and OR staff members
- Adverse events [ Time Frame: Up to 30 days (1 year for prosthetic surgery) ]Rate of postoperative adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961620
|Contact: Xavier Guirao, MD||+34 937 23 10 10 ext firstname.lastname@example.org|
|Principal Investigator:||Xavier Guirao, MD||Parc Tauli Hospital Universitari, Sabadell|