Perioperative Temperature Management (HOT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by VU University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00617136
First received: February 4, 2008
Last updated: January 21, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 VU University Medical Center:

Primary Outcome Measures:
  • Incidence of perioperative hypothermia [ Time Frame: During surgery (1 hour after start warming) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perioperative blood loss [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • Postoperative glucose and insulin levels [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 279
Study Start Date: April 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617136

Contacts
Contact: Marjolein van der Horst, MD +31641430425 m.vanderhorst@vumc.nl
Contact: Ralph Krage, MD +31204444386 r.krage@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Principal Investigator: Marjolein van der Horst, MD         
Spaarne Ziekenhuis Recruiting
Hoofddorp, Netherlands, 2134 TM
Contact: Erik Wiewel, MD    +31238908195    ewiewel@spaarneziekenhuis.nl   
Principal Investigator: Marjolein van der Horst, MD         
Isala Klinieken Recruiting
Zwolle, Netherlands
Contact: C. Olthof, MD, PhD         
Principal Investigator: C. Olthof, MD, PhD         
Sponsors and Collaborators
VU University Medical Center
Investigators
Study Chair: Christa Boer, PhD VU University Medical Center
  More Information

No publications provided

Responsible Party: Dr. Christa Boer, VU University Medical Center
ClinicalTrials.gov Identifier: NCT00617136     History of Changes
Other Study ID Numbers: 2007/235
Study First Received: February 4, 2008
Last Updated: January 21, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on July 28, 2014