Perioperative Temperature Management (HOT)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Hypothermia

Treatments: Device: Intraoperative warming (HotDog); Device: Pre- and intraoperative warming (HotDog); Device: Intraoperative warming (Bair Hugger)

Study type: Interventional

Funder types: Other

Identifiers

NCT00617136

2007/235

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

III

Experimental group

Description:

Prewarming by HotDog

Treatment:

Device: Pre- and intraoperative warming (HotDog)

I

Active Comparator group

Description:

Intraoperative warming by Bair Hugger

Treatment:

Device: Intraoperative warming (Bair Hugger)

II

Active Comparator group

Description:

Intraoperative warming by HotDog

Treatment:

Device: Intraoperative warming (HotDog)