Study to Evaluate the Accuracy of the New Monitor of Temperature in Comparison With the Consecrated Thermometers by Literature

COMPARATIVE STUDY BETWEEN THE USE OF THE "SPOT ON" THERMOMETER AND THE ORAL AND ESOPHAGEAL THERMOMETERS IN SPINAL AND GENERAL ANESTHESIA

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).

Study Overview

• Status: Unknown
• Conditions: Temperature Change, Body
• Intervention / Treatment: Device: Comparative thermometers to compare with a new device

Detailed Description

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 participants that are feverish/present with infectious symptoms
• Refusal of the use of the device by the participants There will be select each groups made up of 70 participants. It will be submitted the adults in two groups, one submitted to general anesthesia and other group submitted to spinal anesthesia and the pediatric group to general anesthesia. The made up for the choice of the thermometer to be to general anesthesia the oral and 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 and after surgery in PACU the Spot On and oral thermometer.

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:

  • Mentrance - entering the room and every 10 min until the anesthesia induction
  • Minduction - immediately before induction
  • M10, M20, M30 = 10, 20, 30 min after induction and every 10 min till the end of the anesthetic procedure;
  • Mpost-0, Mpost-15, Mpost-30, Mdischarge, = 0, 15, 30, and every 15 min till the discharge from post anesthesia recovery room.
• 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).

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Ricardo Caio Gracco md De Bernardis; Phone Number: 5511992773523; Email: rcaiog@yahoo.com.br
• Study Contact Backup: Name: Ligia Andrade da Silva Telles MD Mathias; Phone Number: 5511993860059; Email: rtimao@yahoo.com.br

Study Locations

• Brazil
  • São Paulo
    • Itapecerica da Serra, São Paulo, Brazil, 06854-000
      • Recruiting
      • Hospital Geral de Itapecerica da Serra
      • Contact: Ricardo Caio Gracco md De Bernardis; Phone Number: 5511992773523; Email: rcaiog@yahoo.com.br
      • Contact: Ligia Andrade da Silva Telles MD Mathias; Phone Number: 5511993860059; Email: rtimao@uol.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We will analyze in three different types of anesthesia and population (general and spinal anesthesia and pediatric and adult population)

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

Device: Comparative thermometers to compare with a new 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the Spot On temperature and the consecrated termometer in the perioperative term.	measure the temperature	30 weeks

Collaborators and Investigators

• Sponsor: Ricardo Caio Gracco De Bernardis
• Collaborators: HOSPITAL GERAL DE ITAPECERICA DA SERRA

Publications and helpful links

General Publications

• Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 56202616.9.0000.0083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will publish the data and result after the conclusion of study.

Study Data/Documents

1. Study Protocol
   Information identifier: 56202616.9.0000.0083
   Information comments: There you may find the project and all step to get the approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes