Perioperative Normothermia: Temperature and Prewarming Methods

NCT04011462 | Completed

• 1 other identifier: VPoveda
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypothermia

Keywords

Nursing; Hypothermia; Perioperative Nursing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Prewarming 20 minutes

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.

Device: prewarming 20 minutes

Prewarming 30 minutes

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.

Device: prewarming 30 minutes

Standard care

NO INTERVENTION

warming with cotton sheet and blanket for 20 minutes.

Interventions

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 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.

Prewarming 30 minutes

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: July 8, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: March 30, 2022
• Last Updated: May 4, 2026

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)