Perioperative Normothermia: Temperature and Prewarming Methods

Study Overview
=================
Brief Summary
-----------------
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative Zero-Heat-Flux Cutaneous body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).

Detailed Description
-----------------
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative Zero-Heat-Flux Cutaneous body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)

Official Title
-----------------
Perioperative Normothermia: Temperature and Prewarming Methods

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Device: prewarming 20 minutes
* Device: prewarming 30 minutes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years and over at the time of data collection Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour Exclusion Criteria: Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center Patients submitted to video laparoscopic or minimally invasive surgeries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prewarming 20 minutes<br>prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes. | Device: prewarming 20 minutes<br>* prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.<br>|
| Experimental: Prewarming 30 minutes<br>prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes. | Device: prewarming 30 minutes<br>* prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.<br>|
| No Intervention: Standard care<br>warming with cotton sheet and blanket for 20 minutes. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with temperature below 36 degrees measured by Zero-Heat-Flux Cutaneous body temperature thermometer | Number of patients with temperature below 36 degrees measured by Zero-Heat-Flux Cutaneous body temperature thermometer in comparison to number of patients with temperature below 36 degrees measured by the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). | Perioperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nursing, Hypothermia, Perioperative Nursing