Perioperative Temperature Management

Hypothermia Clinical Trial

— HOT  

Official title:

Perioperative Temperature Management: A Big Small Problem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617136
• Other study ID #: 2007/235
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: December 16, 2014
• Start date: April 2008
• Est. completion date: January 2012

Study information

• Verified date: December 2014
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Intraoperative warming (Bair Hugger)
Intraoperative warming
• Pre- and intraoperative warming (HotDog)
Pre- and intraoperative warming by HotDog
• Intraoperative warming (HotDog)
Intraoperative warming

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Spaarne Ziekenhuis	Hoofddorp
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of perioperative hypothermia		During surgery (1 hour after start warming)	No
Secondary	Perioperative blood loss		During surgery	No
Secondary	Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort		During surgery	No
Secondary	Postoperative glucose and insulin levels		1 hour after surgery	No