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The Use of Thermal Suits as Preventing Hypothermia During Surgery

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ClinicalTrials.gov Identifier: NCT01571544
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Thermal suit Other: Conventional clothing Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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




Primary Outcome Measures :
  1. Temperature [ Time Frame: from one hour before surgery up to the ward after surgery, estimated 10 hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571544


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
Investigators
Principal Investigator: Sirkka-Liisa Lauronen, MD Tampere University Hospital

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01571544     History of Changes
Other Study ID Numbers: R12038
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms