We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative Temperature Management (HOT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00617136
First Posted: February 15, 2008
Last Update Posted: December 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christa Boer, VU University Medical Center
  Purpose
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.

Condition Intervention
Hypothermia Device: Intraoperative warming (Bair Hugger) Device: Pre- and intraoperative warming (HotDog) Device: Intraoperative warming (HotDog)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Perioperative Temperature Management: A Big Small Problem

Resource links provided by NLM:


Further study details as provided by Christa Boer, VU University Medical Center:

Primary Outcome Measures:
  • Incidence of perioperative hypothermia [ Time Frame: During surgery (1 hour after start warming) ]

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

Enrollment: 70
Study Start Date: April 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617136


Locations
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Spaarne Ziekenhuis
Hoofddorp, Netherlands, 2134 TM
Isala Klinieken
Zwolle, Netherlands
Sponsors and Collaborators
VU University Medical Center
Investigators
Study Chair: Christa Boer, PhD VU University Medical Center
  More Information

Responsible Party: Christa Boer, Prof.dr. C. Boer, VU University Medical Center
ClinicalTrials.gov Identifier: NCT00617136     History of Changes
Other Study ID Numbers: 2007/235
First Submitted: February 4, 2008
First Posted: February 15, 2008
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Christa Boer, VU University Medical Center:
Surgery
Anesthesia
Hypothermia
Temperature
Perioperative
Temperature Management

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms