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

NCT03057886 | Unknown DMC FDA Device

• 1 other identifier: 56202616.9.0000.0083
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

• Compare the Spot On temperature and the consecrated termometer in the perioperative term.

  measure the temperature

  30 weeks

Study Arms (1)

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

Interventions

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.

Compare the Spot On with others consecrated thermometers

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

Sponsors & Collaborators

• Ricardo Caio Gracco De Bernardis: lead
• HOSPITAL GERAL DE ITAPECERICA DA SERRA: collaborator

Study Sites (1)

Hospital Geral de Itapecerica da Serra

Itapecerica da Serra, São Paulo, 06854-000, Brazil

RECRUITING

Related Publications (3)

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

  PMID: 18648241 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.

  PMID: 17532957 BACKGROUND

• 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.

  PMID: 19482858 RESULT

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 20, 2017
• Study Start: July 25, 2018
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)