The Use of Thermal Suits as Preventing Hypothermia During Surgery
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Thermal suit
Conventional clothing
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thermal suit
Conventional clothing
Arm Description
Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit.
Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit.
Outcomes
Primary Outcome Measures
Temperature
Secondary Outcome Measures
Full Information
NCT ID
NCT01571544
First Posted
March 29, 2012
Last Updated
January 3, 2017
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01571544
Brief Title
The Use of Thermal Suits as Preventing Hypothermia During Surgery
Official Title
The Use of Thermal Suits as Preventing Hypothermia During Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermal suit
Arm Type
Experimental
Arm Description
Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit.
Arm Title
Conventional clothing
Arm Type
Active Comparator
Arm Description
Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit.
Intervention Type
Device
Intervention Name(s)
Thermal suit
Intervention Description
Thermal suit
Intervention Type
Other
Intervention Name(s)
Conventional clothing
Intervention Description
Conventional clothing
Primary Outcome Measure Information:
Title
Temperature
Time Frame
from one hour before surgery up to the ward after surgery, estimated 10 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirkka-Liisa Lauronen, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
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The Use of Thermal Suits as Preventing Hypothermia During Surgery
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