Suspended

NormothermiaPerioperative Normothermia: Temperature and Prewarming Methods

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What is being tested

prewarming 20 minutes

+ prewarming 30 minutes

Device
Who is being recruted

Body Temperature Changes+1

+ Hypothermia

+ Signs and Symptoms

From 18 to 100 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: July 2019
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2019

Actual date on which the first participant was enrolled.

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 TitlePerioperative Normothermia: Temperature and Prewarming Methods
NCT04011462
Principal SponsorUniversity of Sao Paulo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body Temperature ChangesHypothermiaSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.

Group II

Experimental
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

ICESP

São Paulo, BrazilOpen ICESP in Google Maps
SuspendedOne Study Center
Normothermia | Perioperative Normothermia: Temperature and Prewarming Methods | PatLynk