The Use of Thermal Suits as Preventing Hypothermia During Surgery

Prostate Cancer Clinical Trial

Official title: The Use of Thermal Suits as Preventing Hypothermia During Surgery

Status Completed

Clinical Trial Summary

Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.

Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.

Clinical Trial Description

The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.

A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.

Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.

Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Prostate Cancer

• NCT number: NCT01571544
• Study type: Interventional
• Source: Tampere University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Completion date: November 2014