The Use of Thermal Suits as Preventing Hypothermia During Surgery
This study is currently recruiting participants.
Verified April 2013 by Tampere University Hospital
Sponsor:
Tampere University Hospital
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01571544
First received: March 29, 2012
Last updated: April 3, 2013
Last verified: April 2013
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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: | April 2013 (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, 2013 |
| 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 May 23, 2013