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Compare core body temperature after laparoscopic surgery using the forced air heating system versus the WARMTAC® (a carbon fiber electric blanket).
In order to prevent perioperative hypothermia, we will compare two different heating sistems, one of them is an electric pad made with carbon fiber and the other system is a forced-air blanket. Both of them will be situated under the patient during all the laparoscopic surgey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical heating pad | Experimental | Electrical heating pad (WARMTAC device). Patients will be randomized to one arm. In this arm, the WARMTAC device will be conected and warmed to 41 degrees before patients lay down. |
|
| forced-air warming device | Experimental | Forced-air warming device (3M device). In this arm, the 3M blanket will be conected to forced-air machine and warmed to 41 degrees before patients lay down. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WARMTAC | Device | Randomization to one of the arms previous to surgery. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Core body temperature | temperatured recorded in esophagus | through study completion, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rescues number | Compare number of rescues required by each system to avoid mild hypothermia | through study completion, an average of 12 months |
| skin lesions | Detect possible skin complications related to heating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirea Chanza | Contact | 0034667550215 | mchanza@parcdesalutmar.cat |
| Name | Affiliation | Role |
|---|---|---|
| Mireia Chanza, Physician | PSMar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Recruiting | Barcelona | 08029 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30447894 | Background | Calvo Vecino JM, Casans Frances R, Ripolles Melchor J, Marin Zaldivar C, Gomez Rios MA, Perez Ferrer A, Zaballos Bustingorri JM, Abad Gurumeta A; Grupo de trabajo de la GPC de Hipotermia Perioperatoria No Intencionada de la SEDAR. Clinical practice guideline. Unintentional perioperative hypothermia. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Dec;65(10):564-588. doi: 10.1016/j.redar.2018.07.006. Epub 2018 Nov 15. English, Spanish. | |
| 12697600 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2023 | |
| Unrelease | Sep 27, 2023 | |
| Release | Sep 29, 2023 | |
| Unrelease | Sep 29, 2023 | |
| Release | Oct 20, 2023 | |
| Reset | Apr 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2023 | Sep 27, 2023 | |||
| Sep 29, 2023 | Sep 29, 2023 |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3M Bair Hugger |
| Device |
Randomization to one of the arms previous to surgery. |
|
| through study completion, an average of 12 months |
| Background |
| Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106. |
| 17042850 | Background | Ng V, Lai A, Ho V. Comparison of forced-air warming and electric heating pad for maintenance of body temperature during total knee replacement. Anaesthesia. 2006 Nov;61(11):1100-4. doi: 10.1111/j.1365-2044.2006.04816.x. |
| 26787794 | Background | John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412. |
| Oct 20, 2023 | Apr 12, 2024 |