The Use of Thermal Suits as Preventing Hypothermia During Surgery

This study is currently recruiting participants.
Verified April 2013 by Tampere University Hospital
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01571544
First received: March 29, 2012
Last updated: April 3, 2014
Last verified: April 2013
  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: T-Balance
Other: Control
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 ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thermal suit Device: T-Balance
Thermal suit
Active Comparator: Conventional clothing Other: Control
Normal hospital clothing

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571544

Contacts
Contact: Sirkka-Liisa Lauronen, MD +358 3 31166027 sirkka-liisa.lauronen@pshp.fi
Contact: Heli Leppikangas, MD, PhD + 358 3 311 64866 heli.leppikangas@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Heli Leppikangas, MD, PhD    +358 3 31164866    heli.leppikangas@pshp.fi   
Principal Investigator: Sirkka-Liisa Lauronen, MD         
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: April 3, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Hypothermia
Prostatic Neoplasms
Body Temperature Changes
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014