Optimal Temperature Control in Body Contouring Procedures

NCT06238739 | Completed

• 1 other identifier: NormoT001
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Postoperative Pain; Postoperative Nausea; Postoperative Complications; Postoperative Shivering; Postoperative Hemorrhage

Keywords

Normothermia; Body contouring; Warming blankets; Safety; High-Definition Liposuction

Outcome Measures

Primary Outcomes (6)

• Hypothermia prevention

  Measure the body temperature throughout the procedure

  Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.

• Pain intensity

  Visual analogue scale rating

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

• Chills

  Yes or NO

  Immediately at awakening at the recovery room.

• Shivering

  Yes or NO

  Immediately at awakening at the recovery room.

• Recovery Period

  Time from Operating Room to discharge from the recovery room.

  Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.

• Analgesic requirements

  Measure the amount of analgesic required for pain control

  Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.

Secondary Outcomes (1)

• Cost-effectiveness of each intervention

  Throughout the study completion, about 1 week.

Study Arms (4)

Group 1

PLACEBO COMPARATOR

Standard measures administered to patients

Other: Control - Standard Strategies for hypothermia prevention

Group 2

EXPERIMENTAL

Passive measures

Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration

Group 3

EXPERIMENTAL

Active measures (Blanketrol)

Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration; Device: Thermal convection blanket by water flow (Blanketrol)

Group 4

EXPERIMENTAL

Active measures (HotDog)

Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration; Device: Conductive fabric electric warming device (HotDog)

Interventions

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.

Also known as: Patient warming with Warm-air blankets

Group 1; Group 2; Group 3; Group 4

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.

Also known as: Patient warming with Warm-air Blankets

Group 2; Group 3; Group 4

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).

Also known as: Fluid warming before infusion and infiltration, Patient warming with Warm-air Blankets

Group 3

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).

Also known as: Fluid warming before infusion and infiltration, Patient warming with Warm-air Blankets

Group 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Women with BMI \>30 kg/m²
• men with BMI \>32 kg/m²
• Patients after massive weight loss
• Smokers

Sponsors & Collaborators

• Total Definer Research Group: lead

Study Sites (1)

Dhara clinic

Bogotá, Colombia

Location

Related Publications (3)

• Hoyos AE, Duran H, Cardenas-Camarena L, Bayter JE, Cala L, Perez M, Lopez A, Talleri G, Dominguez-Millan R, Mogollon IR. Use of Tranexamic Acid in Liposculpture: A Double-Blind, Multicenter, Randomized Clinical Trial. Plast Reconstr Surg. 2022 Sep 1;150(3):569-577. doi: 10.1097/PRS.0000000000009434. Epub 2022 Jun 28.

  PMID: 35759637 RESULT

• Enrique Bayter-Marin J, Cardenas-Camarena L, Pena WE, Duran H, Ramos-Gallardo G, Robles-Cervantes JA, McCormick-Mendez M, Rocio Gomez-Gonzalez S, Liliana Plata-Rueda E. Patient Blood Management Strategies to Avoid Transfusions in Body Contouring Operations: Controlled Clinical Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):355-363. doi: 10.1097/PRS.0000000000007524.

  PMID: 33565826 RESULT

• Bayter-Marin JE, Cardenas-Camarena L, Duran H, Valedon A, Rubio J, Macias AA. Effects of Thermal Protection in Patients Undergoing Body Contouring Procedures: A Controlled Clinical Trial. Aesthet Surg J. 2018 Mar 14;38(4):448-456. doi: 10.1093/asj/sjx155.

  PMID: 29087444 RESULT

MeSH Terms

Conditions

Hypothermia; Pain, Postoperative; Postoperative Nausea and Vomiting; Postoperative Complications; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vomiting; Hemorrhage

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Plastic Surgery

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: February 2, 2024
• Study Start: June 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately after publication.
• Access Criteria: Request to the main author

Locations

CO (1)