Optimal Temperature Control in Body Contouring Procedures

Not Applicable

Completed

• Conditions: Hypothermia; Postoperative Nausea; Postoperative Complications; Postoperative Pain; Postoperative Shivering; Postoperative Hemorrhage
• Interventions: Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration; Device: Conductive fabric electric warming device (HotDog); Device: Thermal convection blanket by water flow (Blanketrol)

• Registration Number: NCT06238739
• Lead Sponsor: Total Definer Research Group

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).

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Study First Submitted: 2023-12-09
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4	Fluid warming before infusion and infiltration	Active measures (HotDog)
Group 3	Control - Standard Strategies for hypothermia prevention	Active measures (Blanketrol)
Group 4	Control - Standard Strategies for hypothermia prevention	Active measures (HotDog)
Group 4	Conductive fabric electric warming device (HotDog)	Active measures (HotDog)
Group 2	Fluid warming before infusion and infiltration	Passive measures
Group 1	Control - Standard Strategies for hypothermia prevention	Standard measures administered to patients
Group 2	Control - Standard Strategies for hypothermia prevention	Passive measures
Group 3	Fluid warming before infusion and infiltration	Active measures (Blanketrol)
Group 3	Thermal convection blanket by water flow (Blanketrol)	Active measures (Blanketrol)

Primary Outcome Measures

Name	Time	Method
Chills	Immediately at awakening at the recovery room.	Yes or NO
Pain intensity	Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.	Visual analogue scale rating
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.
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
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dhara clinic; 🇨🇴 Bogota, Colombia