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Completed

NCT Number: NCT04011462

Perioperative Normothermia: Temperature and Prewarming Methods

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).

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICESP

São Paulo, 05403-000, Brazil

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prewarming 20 minutes

Device

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

prewarming 30 minutes

Device

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

Primary outcomes

  1. Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer

    Time frame: Perioperative period

    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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Acronym: Normothermia

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 8, 2019
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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