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Completed

NCT Number: NCT01649596

Impact of Expanded Peri Operative Warming

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Complications Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warming Gown

Device

Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.

Other names: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer

Standard of care warming

Other

The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.

Primary outcomes

  1. Incidence of Hypothermic Events

    Time frame: 12 hours

    The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 12 hours

    Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared.

Sponsors and collaborators

Lead sponsor

Ascension Health

Industry

Collaborators

  • 3M

Registry information

Official study title

Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2012
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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