Perioperative Temperature Management
HOT
1 other identifier
interventional
70
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 17, 2014
December 1, 2014
3.8 years
February 4, 2008
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of perioperative hypothermia
During surgery (1 hour after start warming)
Secondary Outcomes (3)
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 Arms (3)
III
EXPERIMENTALPrewarming by HotDog
I
ACTIVE COMPARATORIntraoperative warming by Bair Hugger
II
ACTIVE COMPARATORIntraoperative warming by HotDog
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing an elective orthopedic knee- or hip replacement
- Participation based on informed consent
- \> 18 years old and \< 85 years old
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
VU University Medical Center
Amsterdam, 1081 HV, Netherlands
Spaarne Ziekenhuis
Hoofddorp, 2134 TM, Netherlands
Isala Klinieken
Zwolle, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christa Boer, PhD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.dr. C. Boer
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 15, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 17, 2014
Record last verified: 2014-12