Perioperative Temperature Management

Study Overview
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Brief Summary
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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
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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

Official Title
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Perioperative Temperature Management: A Big Small Problem

Conditions
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Hypothermia

Intervention / Treatment
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* Device: Intraoperative warming (Bair Hugger)
* Device: Pre- and intraoperative warming (HotDog)
* Device: Intraoperative warming (HotDog)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Anesthesia, Hypothermia, Temperature, Perioperative, Temperature Management