The Use of Thermal Suits as Preventing Hypothermia During Surgery

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Other: Conventional clothing; Device: Thermal suit

Study type: Interventional

Funder types: Other

Identifiers

NCT01571544

R12038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Thermal suit

Experimental group

Description:

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

Treatment:

Device: Thermal suit

Conventional clothing

Active Comparator group

Description:

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

Treatment:

Other: Conventional clothing