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Clinical Trials/NCT00617136
NCT00617136
Completed
Not Applicable

Perioperative Temperature Management: A Big Small Problem

Amsterdam UMC, location VUmc3 sites in 1 country70 target enrollmentApril 2008
ConditionsHypothermia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypothermia
Sponsor
Amsterdam UMC, location VUmc
Enrollment
70
Locations
3
Primary Endpoint
Incidence of perioperative hypothermia
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
January 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Christa Boer

Prof.dr. C. Boer

Amsterdam UMC, location VUmc

Eligibility 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)

Outcomes

Primary Outcomes

Incidence of perioperative hypothermia

Time Frame: During surgery (1 hour after start warming)

Secondary Outcomes

  • Perioperative blood loss(During surgery)
  • Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort(During surgery)
  • Postoperative glucose and insulin levels(1 hour after surgery)

Study Sites (3)

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