NCT01571544

The Use of Thermal Suits as Preventing Hypothermia During Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Thermal suit	Thermal suit
OTHER	Conventional clothing	Conventional clothing

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-04-01
• Completion: 2014-11-01
• First posted: 2012-04-05
• Last updated: 2017-01-04

Locations

1 site across 1 country: Finland