The Use of Thermal Suits as Preventing Hypothermia During Surgery
|ClinicalTrials.gov Identifier: NCT01571544|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : January 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Thermal suit Other: Conventional clothing||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Thermal Suits as Preventing Hypothermia During Surgery|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||November 2014|
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
- Temperature [ Time Frame: from one hour before surgery up to the ward after surgery, estimated 10 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571544
|Tampere University Hospital|
|Tampere, Finland, 33521|
|Principal Investigator:||Sirkka-Liisa Lauronen, MD||Tampere University Hospital|