Thermal Insulation System in Inadvertent Hypothermia (SIT-3c)

Universidade do Porto

Status: Completed

Conditions: Perioperative Hypothermia

Treatments: Device: Layered thermal insulation system

Study type: Interventional

Funder types: Other

Identifiers

NCT05131568

SIT-3c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged over 18 years, with the diagnosis of gonarthrosis, to undergo total elective knee arthroplasty, under neuroaxial anesthesia, who agreed to participate in the study.

Exclusion criteria

• With hypothermia or hyperthermia, scheduled for general anesthesia, pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 2 patient groups

Thermal insulation system

Experimental group

Description:

experimental: layered thermal insulation system The system was applied in the upper body to the entrance of the operating room and remained until the exit of the same room. The test included the evaluation of temperature, tremors and the visual perception of thermal comfort in 6 moments (T1 - reference temperature - at the entrance of the anesthetic induction room, T2 - at the entrance to the operating room, T3, T4 and T5 - fifteen , thirty and forty-five minutes after the start of surgery, and T6 - leaving the operating room)

Treatment:

Device: Layered thermal insulation system

Forced air active warming

No Intervention group

Description:

Control: the same procedures as in the experiment group, were carried out in the control group, except for the intervention.