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Perioperative Temperature Management (HOT)

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intraoperative warming (Bair Hugger)
Pre- and intraoperative warming (HotDog)
Intraoperative warming (HotDog)
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring Surgery, Anesthesia, Hypothermia, Temperature, Perioperative, Temperature Management

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • VU University Medical Center
  • Spaarne Ziekenhuis
  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

III

I

II

Arm Description

Prewarming by HotDog

Intraoperative warming by Bair Hugger

Intraoperative warming by HotDog

Outcomes

Primary Outcome Measures

Incidence of perioperative hypothermia

Secondary Outcome Measures

Perioperative blood loss
Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort
Postoperative glucose and insulin levels

Full Information

First Posted
February 4, 2008
Last Updated
December 16, 2014
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT00617136
Brief Title
Perioperative Temperature Management
Acronym
HOT
Official Title
Perioperative Temperature Management: A Big Small Problem
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Surgery, Anesthesia, Hypothermia, Temperature, Perioperative, Temperature Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
III
Arm Type
Experimental
Arm Description
Prewarming by HotDog
Arm Title
I
Arm Type
Active Comparator
Arm Description
Intraoperative warming by Bair Hugger
Arm Title
II
Arm Type
Active Comparator
Arm Description
Intraoperative warming by HotDog
Intervention Type
Device
Intervention Name(s)
Intraoperative warming (Bair Hugger)
Intervention Description
Intraoperative warming
Intervention Type
Device
Intervention Name(s)
Pre- and intraoperative warming (HotDog)
Intervention Description
Pre- and intraoperative warming by HotDog
Intervention Type
Device
Intervention Name(s)
Intraoperative warming (HotDog)
Intervention Description
Intraoperative warming
Primary Outcome Measure Information:
Title
Incidence of perioperative hypothermia
Time Frame
During surgery (1 hour after start warming)
Secondary Outcome Measure Information:
Title
Perioperative blood loss
Time Frame
During surgery
Title
Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort
Time Frame
During surgery
Title
Postoperative glucose and insulin levels
Time Frame
1 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christa Boer, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Spaarne Ziekenhuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

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Perioperative Temperature Management

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