The Use of Thermal Suits as Preventing Hypothermia During Surgery

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Thermal suit; Other: Conventional clothing

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal suit; Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit.	Device: Thermal suit; Thermal suit
Active Comparator: Conventional clothing; Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit.	Other: Conventional clothing; Conventional clothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Temperature	from one hour before surgery up to the ward after surgery, estimated 10 hours

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Sirkka-Liisa Lauronen, MD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: R12038