NCT01571544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 prostate-cancer

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

March 29, 2012

Last Update Submit

January 3, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Temperature

    from one hour before surgery up to the ward after surgery, estimated 10 hours

Study Arms (2)

Thermal suit

EXPERIMENTAL

Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit.

Device: Thermal suit

Conventional clothing

ACTIVE COMPARATOR

Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit.

Other: Conventional clothing

Interventions

Thermal suitDEVICE

Thermal suit

Thermal suit
Conventional clothingOTHER

Conventional clothing

Conventional clothing

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90

You may not qualify if:

  • mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Sirkka-Liisa Lauronen, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 5, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

November 1, 2014

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

FI(1)