Perioperative Temperature Management (HOT)

A

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

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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