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Completed

NCT Number: NCT06238739

Optimal Temperature Control in Body Contouring Procedures

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Hemorrhage Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Postoperative Nausea Postoperative Nausea and Vomiting Postoperative Pain Postoperative Shivering Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhara clinic

Bogotá, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control - Standard Strategies for hypothermia prevention

Other

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.

Other names: Patient warming with Warm-air blankets

Fluid warming before infusion and infiltration

Other

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.

Other names: Patient warming with Warm-air Blankets

Thermal convection blanket by water flow (Blanketrol)

Device

Blanketrol: Patients underwent continuous intra-operative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F).

Other names: Fluid warming before infusion and infiltration, Patient warming with Warm-air Blankets

Conductive fabric electric warming device (HotDog)

Device

HotDog: Patients underwent permanent intra-operative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).

Other names: Fluid warming before infusion and infiltration, Patient warming with Warm-air Blankets

Primary outcomes

  1. Hypothermia prevention

    Time frame: 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

  2. Pain intensity

    Time frame: Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.

    Visual analogue scale rating

  3. Chills

    Time frame: Immediately at awakening at the recovery room.

    Yes or NO

  4. Shivering

    Time frame: Immediately at awakening at the recovery room.

    Yes or NO

  5. Recovery Period

    Time frame: 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.

  6. Analgesic requirements

    Time frame: 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

Secondary outcomes

  1. Cost-effectiveness of each intervention

    Time frame: Throughout the study completion, about 1 week.

    Analysis of overall costs and effects on patient recovery among the different groups.

Sponsors and collaborators

Lead sponsor

Total Definer Research Group

Other

Registry information

Official study title

Impact of Optimal Temperature Control in Body Contouring Surgery: A Non-Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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