An interventional study of Control and Nursing in Hypothermia, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Not applicable, Interventional, and Prevention
Literature establishes that warming with a heated blanket before and during the operation is effective in the prevention of perioperative hypothermia, both in general anesthesia as well as spinal anesthesia. However, the trials have still not presented us with objective protocols to standardize this routine in the surgical centers.
The study aims to assess the adoption and reproduction of the implementation of the warning device by the nursing team immediately after the patient's entrance in the operating room, even before the entrance of the anesthesiologist.
After approval by the Institutional Research Ethics Committee, the patients for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the central operating center at Santa Casa de Misericórdia in São Paulo will be assessed over a period of 60 days. The patients will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, they will be included.
Inclusion/exclusion criteria:
Inclusion - adults that will be submitted to general or spinal anesthesia in the central operating center at Santa Casa de Misericórdia in São Paulo.
Exclusion:
All the patients scheduled with elective surgery predicted to last over 60 minutes will be selected and there will be an assessment of the number of cases in which the protocol was followed and the time of use of the warming device will be monitored from the installation entrance in the OR and before the anesthesia induction and every 30 minutes beginning of anesthesia, during the surgery until the end of the anesthetic procedure.
The variables to be assessed in the study are:
Oral temperature measured at the following points:
Arterial oxygen saturation; heart beat; systolic and diastolic pressure and carbon dioxide expired:
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's enrollment of 300 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 41 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Nursing Group (Nurse): the nursing team will use of the warming device air flow device from the moment the patients enter the operating room until anesthesia induction. The warming device will be set up connected to the patient and to the motor with the activation of the system at 43°C by the nursing team. The monitoring of the times since the entrance of the patient in the operating room until the induction of the anesthesia will be controlled by a member of the anesthesia team (regardless of the room process);
Procedure: Control · Procedure: Nursing
All previously selected patients will be under passive warming by means of blankets
All previously selected patients will be under active air flow warming device at 43 Celsius
Body temperature
temperature from entrance in surgical room to ending of anesthesia state
Time frame: 120 minutes
Ran from Jul 2015 to primary completion in Feb 2016, 7 months.
Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 7 months is below that.
Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Faculdade de Ciências Médicas da Santa Casa de São Paulo