Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Four different protocols will be used for patient peroperative preparation for normothermia.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Standard measures administered to patients |
|
| Group 2 | Experimental | Passive measures |
|
| Group 3 | Experimental | Active measures (Blanketrol) |
|
| Group 4 | Experimental | Active measures (HotDog) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of each intervention | Analysis of overall costs and effects on patient recovery among the different groups. | Throughout the study completion, about 1 week. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhara clinic | Bogotá | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35759637 | Result | 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. | |
| 33565826 | Result |
Not provided
Not provided
Depending upon reasonable request
Immediately after publication.
Request to the main author
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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). |
|
|
| 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). |
|
|
| 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. |
| 29087444 | 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. |
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D011183 | Postoperative Complications |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D006470 | Hemorrhage |
Not provided
Not provided