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.
|Prostate Cancer||Device: Thermal suit Other: Conventional clothing||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Use of Thermal Suits as Preventing Hypothermia During Surgery|
- Temperature [ Time Frame: from one hour before surgery up to the ward after surgery, estimated 10 hours ]
|Study Start Date:||November 2012|
|Study Completion Date:||November 2014|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571544
|Tampere University Hospital|
|Tampere, Finland, 33521|
|Principal Investigator:||Sirkka-Liisa Lauronen, MD||Tampere University Hospital|