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Completed

NCT Number: NCT00617136

Perioperative Temperature Management

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center, Amsterdam, Netherlands

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intraoperative warming (Bair Hugger)

Device

Intraoperative warming

Pre- and intraoperative warming (HotDog)

Device

Pre- and intraoperative warming by HotDog

Intraoperative warming (HotDog)

Device

Intraoperative warming

Primary outcomes

  1. Incidence of perioperative hypothermia

    Time frame: During surgery (1 hour after start warming)

Secondary outcomes

  1. Perioperative blood loss

    Time frame: During surgery

  2. Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort

    Time frame: During surgery

  3. Postoperative glucose and insulin levels

    Time frame: 1 hour after surgery

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Perioperative Temperature Management: A Big Small Problem

Acronym: HOT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2008
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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