The Use of Thermal Suits as Preventing Hypothermia During Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Thermal Suits as Preventing Hypothermia During Surgery

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Thermal suit
* Other: Conventional clothing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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