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

Temperature Change, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057886
• Other study ID #: 56202616.9.0000.0083
• Status: Recruiting
• Start date: July 25, 2018
• Est. completion date: May 2019

Study information

• Verified date: July 2018
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: Ricardo Caio Gracco MD De Bernardis
• Phone: 5511992773523
• Email: rcaiog[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Temperature Change, Body

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Geral de Itapecerica da Serra	Itapecerica da Serra	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Ricardo Caio Gracco De Bernardis	HOSPITAL GERAL DE ITAPECERICA DA SERRA

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Spot On temperature and the consecrated termometer in the perioperative term.	measure the temperature	30 weeks