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The Use of Thermal Suits as Preventing Hypothermia During Surgery

The Use of Thermal Suits as Preventing Hypothermia During Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01571544
Enrollment
100
Registered
2012-04-05
Start date
2012-11-30
Completion date
2014-11-30
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

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. 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.

Interventions

Thermal suit

OTHERConventional clothing

Conventional clothing

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Temperaturefrom one hour before surgery up to the ward after surgery, estimated 10 hours

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026