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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| III | Experimental | Prewarming by HotDog |
|
| I | Active Comparator | Intraoperative warming by Bair Hugger |
|
| II | Active Comparator | Intraoperative warming by HotDog |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative warming (Bair Hugger) | Device | Intraoperative warming |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perioperative hypothermia | During surgery (1 hour after start warming) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christa Boer, PhD | Amsterdam UMC, location VUmc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Amsterdam | 1081 HV | Netherlands | |||
| Spaarne Ziekenhuis |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pre- and intraoperative warming (HotDog) |
| Device |
Pre- and intraoperative warming by HotDog |
|
| Intraoperative warming (HotDog) | Device | Intraoperative warming |
|
| 1 hour after surgery |
| Hoofddorp |
| 2134 TM |
| Netherlands |
| Isala Klinieken | Zwolle | Netherlands |