The Use of Thermal Suits as Preventing Hypothermia During Surgery

Prostate Cancer Clinical Trial

Official title:

The Use of Thermal Suits as Preventing Hypothermia During Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571544
• Other study ID #: R12038
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2012
• Last updated: January 3, 2017
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: January 2017
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Prostate Cancer

Intervention

Device:
• Thermal suit
Thermal suit

Other:
• Conventional clothing
Conventional clothing

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature		from one hour before surgery up to the ward after surgery, estimated 10 hours	No