Optimal Temperature Control in Body Contouring Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia

NCT02905708

Hypothermia

COMPLETED NA

Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia

NCT02079311

Inadvertent Perioperative Hypothermia Preoperative Anxiety Experienced by the Patient

COMPLETED NA

Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

NCT01502163

Perioperative Hypothermia

COMPLETED NA

Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia

NCT04410068

Temperature Change, Body Hypothermia; Anesthesia

UNKNOWN NA

Perioperative Normothermia: Temperature and Prewarming Methods

NCT04011462

Hypothermia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothermia Postoperative Pain Postoperative Nausea Postoperative Complications Postoperative Shivering Postoperative Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Standard measures administered to patients

Group Type PLACEBO_COMPARATOR

Control - Standard Strategies for hypothermia prevention

Intervention Type 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.

Group 2

Passive measures

Group Type EXPERIMENTAL

Control - Standard Strategies for hypothermia prevention

Intervention Type 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.

Fluid warming before infusion and infiltration

Intervention Type 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.

Group 3

Active measures (Blanketrol)

Group Type EXPERIMENTAL

Control - Standard Strategies for hypothermia prevention

Intervention Type 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.

Fluid warming before infusion and infiltration

Intervention Type 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.

Thermal convection blanket by water flow (Blanketrol)

Intervention Type DEVICE

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

Group 4

Active measures (HotDog)

Group Type EXPERIMENTAL

Control - Standard Strategies for hypothermia prevention

Intervention Type 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.

Fluid warming before infusion and infiltration

Intervention Type 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.

Conductive fabric electric warming device (HotDog)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control - 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.

Intervention Type OTHER

Fluid 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.

Intervention Type OTHER

Thermal 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).

Intervention Type DEVICE

Conductive 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).

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Patient warming with Warm-air blankets Patient warming with Warm-air Blankets Fluid warming before infusion and infiltration Patient warming with Warm-air Blankets Fluid warming before infusion and infiltration Patient warming with Warm-air Blankets

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)