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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057886
Recruitment Status : Unknown
Verified July 2018 by Ricardo Caio Gracco De Bernardis, Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Recruitment status was:  Recruiting
First Posted : February 20, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
HOSPITAL GERAL DE ITAPECERICA DA SERRA
Information provided by (Responsible Party):
Ricardo Caio Gracco De Bernardis, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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).

Condition or disease Intervention/treatment
Temperature Change, Body Device: Comparative thermometers to compare with a new device

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 210 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: COMPARATIVE STUDY BETWEEN THE USE OF THE "SPOT ON" THERMOMETER AND THE ORAL AND ESOPHAGEAL THERMOMETERS IN SPINAL AND GENERAL ANESTHESIA
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

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.




Primary Outcome Measures :
  1. Compare the Spot On temperature and the consecrated termometer in the perioperative term. [ Time Frame: 30 weeks ]
    measure the temperature



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057886


Contacts
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Contact: Ricardo Caio Gracco MD De Bernardis 5511992773523 rcaiog@yahoo.com.br
Contact: Ligia Andrade da Silva Telles MD Mathias 5511993860059 rtimao@yahoo.com.br

Locations
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Brazil
Hospital Geral de Itapecerica da Serra Recruiting
Itapecerica da Serra, São Paulo, Brazil, 06854-000
Contact: Ricardo Caio Gracco md De Bernardis    5511992773523    rcaiog@yahoo.com.br   
Contact: Ligia Andrade da Silva Telles MD Mathias    5511993860059    rtimao@uol.com.br   
Sponsors and Collaborators
Ricardo Caio Gracco De Bernardis
HOSPITAL GERAL DE ITAPECERICA DA SERRA
Additional Information:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 56202616.9.0000.0083
There you may find the project and all step to get the approval

Publications of Results:
Other Publications:
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Responsible Party: Ricardo Caio Gracco De Bernardis, PHD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03057886    
Other Study ID Numbers: 56202616.9.0000.0083
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will publish the data and result after the conclusion of study.

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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
Additional relevant MeSH terms:
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Body Temperature Changes