The Use of Thermal Suits as Preventing Hypothermia During Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01571544
First received: March 29, 2012
Last updated: December 12, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Device: Thermal suit
Other: Conventional clothing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Thermal Suits as Preventing Hypothermia During Surgery

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Temperature [ Time Frame: from one hour before surgery up to the ward after surgery, estimated 10 hours ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2012
Study Completion Date: November 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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. Inclusion criteria were age between 18 and 90 years and ASA score I-III. Exclusion criteria were descended mental status, muscular diseases or Raynaud disease. Also patients with unstable coronary artery disease were excluded. 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 esofagus (core temperature), left axilla, dorsal surface of the left middlefinger and back of the left foot.

Anesthesia was induced via TCI. All temperature data of the patients were collected and recorded electrically and continuously.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • radical prostatectomy, ASA I-III, age 18-90

Exclusion Criteria:

  • mental status with inability to give informed consent, neuromuscular disorders, Raynaud`s disease, unstable angina pectoris
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01571544     History of Changes
Other Study ID Numbers: R12038
Study First Received: March 29, 2012
Last Updated: December 12, 2014
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on March 30, 2015