Impact of Expanded Peri Operative Warming

Ascension Health

Status: Completed

Conditions: Complications; Hypothermia

Treatments: Device: Warming Gown; Other: Standard of care warming

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649596

GRMC120009

Details and patient eligibility

About

The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.

Full description

This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.

This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects are adult patients 18 years and older elective surgery of > 1 hour

Exclusion criteria

• Emergency and/or trauma cases
• Patients with diminished mental capacity unable to fill out or respond to survey questions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Warming Gown

Active Comparator group

Description:

Comparison of two types of warming processes prior to, during, and after the surgery procedure.

Treatment:

Device: Warming Gown

Standard of Care Warming

Other group

Description:

Standard of care warming with hospital-issued blankets.

Treatment:

Other: Standard of care warming