Perioperative Normothermia: Temperature and Prewarming Methods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre Warming Protocol Implementation in Operation Room

NCT05573152

Hypothermia

COMPLETED NA

Prewarming Effect in Preventing Perioperative Hypothermia

NCT02422758

Hypothermia

UNKNOWN PHASE3

Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia

NCT04027842

Hypothermia; Anesthesia

COMPLETED NA

Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia

NCT01026766

Hypothermia

COMPLETED

10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

NCT04991272

Urologic Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothermia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prewarming 20 minutes

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 Type EXPERIMENTAL

prewarming 20 minutes

Intervention Type 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

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

Group Type EXPERIMENTAL

prewarming 30 minutes

Intervention Type 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.

Standard care

warming with cotton sheet and blanket for 20 minutes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prewarming 20 minutes

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

Intervention Type DEVICE

prewarming 30 minutes

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No