Perioperative Normothermia: Temperature and Prewarming Methods

University of Sao Paulo

Status: Unknown

Conditions: Hypothermia

Treatments: Device: prewarming 30 minutes; Device: prewarming 20 minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT04011462

VPoveda

Details and patient eligibility

About

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).

Full 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)

Enrollment: 105 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Prewarming 20 minutes

Experimental group

Description:

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

Treatment:

Device: prewarming 20 minutes

Prewarming 30 minutes

Experimental group

Description:

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

Treatment:

Device: prewarming 30 minutes

Standard care

No Intervention group

Description:

warming with cotton sheet and blanket for 20 minutes.