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| Name | Class |
|---|---|
| HOSPITAL GERAL DE ITAPECERICA DA SERRA | UNKNOWN |
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This study compares the use of the "SPOT ON" thermometer with the oral, esophageal in participants submitted to general and the oral thermometer to spinal anesthesia, from the pre op, intra and post op stages, evaluating the accuracy of this new monitor against the already consecrated one by literature. The Investigators will analyze in three different types of anesthesia (general, spinal and pediatric population).
After approval by the Institutional Research Ethics Committee, the adults and pediatrics participants for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the surgery center at Itapecerica of Serra Hospital. The participants will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, the participants will be included.
Inclusion/exclusion criteria:
Inclusion - adults and pediatrics population that will be submitted to general or spinal anesthesia in the surgery center at Itapecerica of Serra Hospital.
Exclusion:
The thermometer will be used as the moment they will be identified as:
Adult General Group (AGG): the anesthetic procedure will use the spot on thermometer during the pre, intra and post-operative stages and in association with oral during the pre, intra and post-operative stages and the esophagus thermometer during the intra-operative stage.
Adult Spinal Group (ASG): the anesthetic procedure will use the oral and the spot on thermometer in the pre, intra and post-operative stages.
Pediatric General Group (ASG): the anesthetic procedure will use the oral in the pre, intra and post-operative stages and esophageal thermometers in the intra stages and the spot on thermometer during the pre, intra and post-operative stages.
The anesthetic technique will be standard according to the scheduled surgery. The study will assess the participants submitted to elective anesthesia throughout the pre, intra and post-operative stages of all scheduled elective surgeries.
All the participants for elective surgeries lasting 60 minutes or more and/or are scheduled to use any active heating device from the pre, intra and post-anesthetic stages up till the discharge from the post anesthesia recovery room.
The variables to be assessed in the study are:
Age, gender, weight, height, physical condition according to the American Anesthesiology Association classification;
Oral, SPOT ON, and esophagus temperature measured at the following points:
Room temperature of operating room and post anesthesia recovery room (from the participants entrance every 30 minutes to the end of the procedure and discharge to the hospital bed).
Data analysis The data will be tabulated and noted as mean and standard deviation, whenever possible, and observed for normal distribution using the Kolmogorov-Smirnov test (sample size exceeding 50). Nonparametric data will be presented by Mid and distribution boundaries. The values of temperatures are compared by estimation model of generalized equations (GEE) with Bonferroni correction (REF: Guimarães and Hirakata, 2012).
The calculation of the sample consider the participants as his own control (intragroup) and also the comparison between the equipment used (between groups, all three). Using multivariate analysis of variance (ANOVA) repeated measures, with test significance level (alpha) 1% (probability of error type I) and sample size which reduces the probability of type II error (Beta) in 95%, the sample is situated on 120 participants(Ref: Faul et al 2007).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compare the Spot On with others consecrated thermometers | This study intends to compare the accuracy of the new device(SPOT ON thermometer) with the oral and esophageal in participants submitted to general and spinal anesthesia, in different types of population (pediatric and adult) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparative thermometers to compare with a new device | Device | The made up for the choice of the thermometer to be to general anesthesia the oral and new device (Spot On thermometers) before anesthesia induction, after anesthesia induction the Spot On, and oral, and esophageal thermometers and after surgery in PACU the Spot On and oral thermometer. In group submitted to spinal anesthesia the made up for the choice of the thermometer to be the oral and Spot On thermometers before anesthesia induction, after anesthesia induction the Spot On and oral thermometers and after surgery in PACU the Spot On and oral thermometer. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Spot On temperature and the consecrated termometer in the perioperative term. | measure the temperature | 30 weeks |
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The participants for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the central operating center at the Itapecerica da Serra Hospital.
The participants will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, they will be included.
Inclusion Criteria: adults and pediatrics population that will be submitted to general or spinal anesthesia in the surgery center at Itapecerica of Serra Hospital.
Exclusion Criteria:• Patients that are feverish/present with infectious symptoms and Refusal of the use of the device by the patient
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We will analyze in three different types of anesthesia and population (general and spinal anesthesia and pediatric and adult population)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Caio Gracco MD De Bernardis | Contact | 5511992773523 | rcaiog@yahoo.com.br | |
| Ligia Andrade da Silva Telles MD Mathias | Contact | 5511993860059 | rtimao@yahoo.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Geral de Itapecerica da Serra | Recruiting | Itapecerica da Serra | São Paulo | 06854-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18648241 | Background | Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76. | |
| 17532957 | Background | Akata T, Setoguchi H, Shirozu K, Yoshino J. Reliability of temperatures measured at standard monitoring sites as an index of brain temperature during deep hypothermic cardiopulmonary bypass conducted for thoracic aortic reconstruction. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1559-65. doi: 10.1016/j.jtcvs.2006.11.031. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 56202616.9.0000.0083 | Study Protocol | View IPD |
We will publish the data and result after the conclusion of study.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2019 | |
| Reset | Oct 4, 2019 | |
| Release | Mar 4, 2021 |
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| 19482858 | Result | Kimberger O, Thell R, Schuh M, Koch J, Sessler DI, Kurz A. Accuracy and precision of a novel non-invasive core thermometer. Br J Anaesth. 2009 Aug;103(2):226-31. doi: 10.1093/bja/aep134. Epub 2009 May 29. |
There you may find the project and all step to get the approval |
| Reset | Mar 29, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2019 | Oct 4, 2019 | |||
| Mar 4, 2021 | Mar 29, 2021 |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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