The Use of Thermal Suits as Preventing Hypothermia During Surgery

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Conventional clothing; Device: Thermal suit

• Registration Number: NCT01571544
• Lead Sponsor: Tampere University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Study Start: 2012-11
• Primary Completion: 2013-04
• Study Completion: 2014-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90

Exclusion Criteria

• mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional clothing	Conventional clothing	Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit.
Thermal suit	Thermal suit	Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit.

Primary Outcome Measures

Name	Time	Method
Temperature	from one hour before surgery up to the ward after surgery, estimated 10 hours

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland