Perioperative Temperature Management (HOT)

December 16, 2014 updated by: Christa Boer, Amsterdam UMC, location VUmc

Perioperative Temperature Management: A Big Small Problem

The investigators aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothermia, defined as a core temperature below 36 degrees celsius, is commonly seen in patients undergoing surgery. Intraoperative hypothermia is related to postoperative patient discomfort, impaired wound healing, increased blood loss, anxiety and disturbances in glucose and insulin levels. Prewarming of patients prior to surgery may result in maintenance of intraoperative temperature and reduce postoperative complications. We therefore aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

Objective of the study:

Does preoperative heating of patients undergoing elective orthopedic surgery reduce the incidence of intraoperative hypothermia and postoperative comfort and modulate postoperative glucose and insulin blood levels?

Study design:

Multi-center, prospective, randomized clinical trial.

Study population:

Patients undergoing an elective orthopedic hip- or knee replacement

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing an elective orthopedic knee- or hip replacement
  • Participation based on informed consent
  • > 18 years old and < 85 years old

Exclusion Criteria:

  • BMI 18.5 > x < 40
  • Pregnancy
  • Non elective trauma patients
  • Infectious or febrile patients (> 37.5oC)
  • Diabetes Mellitus
  • Combined surgery
  • Anemia (Hb < 4.0 mmol/l)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: III
Prewarming by HotDog
Device: Pre- and intraoperative warming (HotDog)
Pre- and intraoperative warming by HotDog
Active Comparator: I
Intraoperative warming by Bair Hugger
Device: Intraoperative warming (Bair Hugger)
Intraoperative warming
Active Comparator: II
Intraoperative warming by HotDog
Device: Intraoperative warming (HotDog)
Intraoperative warming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of perioperative hypothermia
Time Frame: During surgery (1 hour after start warming)
During surgery (1 hour after start warming)

Secondary Outcome Measures

Outcome Measure
Time Frame
Perioperative blood loss
Time Frame: During surgery
During surgery
Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort
Time Frame: During surgery
During surgery
Postoperative glucose and insulin levels
Time Frame: 1 hour after surgery
1 hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Study Chair: Christa Boer, PhD, Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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