Perioperative Temperature Management

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Device: Pre- and intraoperative warming (HotDog); Device: Intraoperative warming (Bair Hugger); Device: Intraoperative warming (HotDog)

• Registration Number: NCT00617136
• Lead Sponsor: Amsterdam UMC, location VUmc

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

Study Timeline

• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Study Start: 2008-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
III	Pre- and intraoperative warming (HotDog)	Prewarming by HotDog
I	Intraoperative warming (Bair Hugger)	Intraoperative warming by Bair Hugger
II	Intraoperative warming (HotDog)	Intraoperative warming by HotDog

Primary Outcome Measures

Name	Time	Method
Incidence of perioperative hypothermia	During surgery (1 hour after start warming)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

Spaarne Ziekenhuis; 🇳🇱 Hoofddorp, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands