Hypothermia, Postoperative Complications, Postoperative Hemorrhage, Postoperative Nausea, Postoperative Pain, Postoperative Shivering
Conditions
Keywords
Normothermia, Body contouring, Warming blankets, Safety, High-Definition Liposuction
Brief summary
The goal of this clinical trial is to compare different strategies for normothermia prevention in patients undergoing body contouring and other Aesthetic Plastic Surgery procedures. The main question(s) it aims to answer are: * Do active measures have an impact on preventing hypothermia in patients undergoing cosmetic procedures? * Does an active normothermia prevention protocol have any impact in the clinical setting? Four different protocols will be used for patient peroperative preparation for normothermia.
Detailed description
Participants will receive either of four different protocols for normothermia: Group 1 (Control) involved patients with standard temperature management according to regular institutional protocol, without preoperative or intraoperative thermal protection measures. Group 2 (Passive thermal protection measures) had patients who underwent one-hour preoperative warming with hot air at 38°C (100.4°F), the operating room (OR) temperature was maintained at a minimum of 21°C (69.8°F), aseptic/antiseptic solutions along with infiltration fluid were all warmed to 38°C (100.4°F), and surgical fields were kept as dry as possible. In Group 3 (Active thermal protection measures), patients received the same measures as Group 2, adding continuous intraoperative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F). Group 4 (active thermal protection measures) included patients with the same measures as Group 2, adding permanent intraoperative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).
Interventions
OTHERControl - Standard Strategies for hypothermia prevention
Standard temperature management. Patients underwent one-hour pre- and post-operative warming with hot-air warming blankets at 38°C, without any other preoperative or intraoperative thermal protection measure.
OTHERFluid warming before infusion and infiltration
Passive Measures: Patients underwent one-hour preoperative warming with hot air warming blankets at 38°C (100.4°F), operating room (OR) temperature was maintained at a minimum of 21°C (69.8°F), aseptic/antiseptic solutions along with infiltration fluid were all warmed to 38°C (100.4°F), and surgical fields were kept as dry as possible.
DEVICEThermal convection blanket by water flow (Blanketrol)
Blanketrol: Patients underwent continuous intra-operative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F).
DEVICEConductive fabric electric warming device (HotDog)
HotDog: Patients underwent permanent intra-operative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).
Sponsors
Total Definer Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermolipectomy. * Healthy patients without underlying comorbidities (classified as ASA≤II)
Exclusion criteria
* Women with BMI \>30 kg/m² * men with BMI \>32 kg/m² * Patients after massive weight loss * Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chills | Immediately at awakening at the recovery room. | Yes or NO |
| Hypothermia prevention | Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge. | Measure the body temperature throughout the procedure |
| Pain intensity | Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge. | Visual analogue scale rating |
| Analgesic requirements | Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery. | Measure the amount of analgesic required for pain control |
| Shivering | Immediately at awakening at the recovery room. | Yes or NO |
| Recovery Period | Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge. | Time from Operating Room to discharge from the recovery room. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of each intervention | Throughout the study completion, about 1 week. | Analysis of overall costs and effects on patient recovery among the different groups. |
Countries
Colombia
Outcome results
None listed