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HypothermiaNCT06238739

Optimal Temperature Control in Body Contouring Procedures

A study testing Fluid warming before infusion and infiltration, Thermal convection blanket by water flow (Blanketrol) and Conductive fabric electric warming device (HotDog) in people with Hypothermia and Postoperative Pain, run by Total Definer Research Group at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Fluid warming before infusion and infiltration, Thermal convection blanket by water flow (Blanketrol) and Conductive fabric electric warming device (HotDog)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
197 participants
Where
1 siteColombia
Study dates
1 Jun 2022to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Dhara clinic

    Bogotá

Other trials in Colombia

About this study

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

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.

Read the 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).

Being tested
Control - Standard Strategies for hypothermia prevention, Fluid warming before infusion and infiltration, Thermal convection blanket by water flow (Blanketrol), Conductive fabric electric warming device (HotDog)
Keywords
Normothermia, Body contouring, Warming blankets, Safety, High-Definition Liposuction
Medical subject headings
Hypothermia, Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications, Postoperative Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control - Standard Strategies for hypothermia preventionOther

    Also called Patient warming with Warm-air blankets

    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.

  • Fluid warming before infusion and infiltrationOther

    Also called Patient warming with Warm-air Blankets

    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.

  • Thermal convection blanket by water flow (Blanketrol)Device

    Also called Fluid warming before infusion and infiltration, Patient warming with Warm-air Blankets

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

  • Conductive fabric electric warming device (HotDog)Device

    Also called Fluid warming before infusion and infiltration, Patient warming with Warm-air Blankets

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

Study groups in NCT06238739
Study groupRoleWhat they receive
Group 1Placebo comparatorStandard measures administered to patients
Receives: Other: Control - Standard Strategies for hypothermia prevention
Group 2ExperimentalPassive measures
Receives: Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration
Group 3ExperimentalActive measures (Blanketrol)
Receives: Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration; Device: Thermal convection blanket by water flow (Blanketrol)
Group 4ExperimentalActive measures (HotDog)
Receives: Other: Control - Standard Strategies for hypothermia prevention; Other: Fluid warming before infusion and infiltration; Device: Conductive fabric electric warming device (HotDog)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypothermia prevention

    Measure the body temperature throughout the procedure

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

  2. Pain intensity

    Visual analogue scale rating

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

  3. Chills

    Yes or NO

    Measured: Immediately at awakening at the recovery room.

  4. Shivering

    Yes or NO

    Measured: Immediately at awakening at the recovery room.

  5. Recovery Period

    Time from Operating Room to discharge from the recovery room.

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

  6. Analgesic requirements

    Measure the amount of analgesic required for pain control

    Measured: 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)

  1. Cost-effectiveness of each intervention

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

    Measured: Throughout the study completion, about 1 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start1 Jun 2022
  3. Primary completion30 Jul 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06238739
Sponsor's protocol ID
NormoT001
Status last verified
Jan 2024
First submitted
9 Dec 2023
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Depending upon reasonable request

Publications

  • 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.

    PubMed 35759637

  • 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.

    PubMed 33565826

  • 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.

    PubMed 29087444

Questions about this trial

What is this clinical trial studying?

A study testing Fluid warming before infusion and infiltration, Thermal convection blanket by water flow (Blanketrol) and Conductive fabric electric warming device (HotDog) in people with Hypothermia and Postoperative Pain, run by Total Definer Research Group at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06238739, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

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