NCT05131568

Thermal Insulation System in Inadvertent Hypothermia

Efficacy of a Thermal Insulation System in Inadvertent Hypothermia and Perioperative Comfort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares the effectiveness of a new layered thermal insulation system (SIT-3c) versus the traditional thermal body protection (warmed forced air system) for patients under total knee arthroplasty, during the intra-operative phase.

Detailed description

Protecting patients from the cold in the operating room is a complex problem that has encouraged the search for better and more effective thermal protection systems. Some disadvantages have been observed in the daily use of the recommended thermal protection system (forced warm air). This study intends to design and evaluate the effectiveness of a three-layer thermal insulation system, comparing its effect with the forced warm air system on temperature variation, shivering incidence and comfort perception, in patients undergoing total knee arthroplasty under neuro-axial anesthesia, during the intra-operative phase. Participants are randomly assigned to the experimental group (EG) or control group (CG). The experimental group receives as a skin protection the three-layer thermal insulation system (SIT-3c) and the control group receives the usual recommended system (forced warm air). Both systems are placed at the entrance to the operating room and held on patients during the entire intra-operative phase.

Conditions

• Perioperative Hypothermia

Interventions

Type	Name	Description
DEVICE	Layered thermal insulation system	No other intervention

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2021-11-23
• Last updated: 2023-03-31

Locations

1 site across 1 country: Portugal