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Perioperative Temperature Management

NCT ID: NCT00617136

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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

Conditions

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Hypothermia

Keywords

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Surgery Anesthesia Hypothermia Temperature Perioperative Temperature Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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III

Prewarming by HotDog

Group Type EXPERIMENTAL

Pre- and intraoperative warming (HotDog)

Intervention Type DEVICE

Pre- and intraoperative warming by HotDog

I

Intraoperative warming by Bair Hugger

Group Type ACTIVE_COMPARATOR

Intraoperative warming (Bair Hugger)

Intervention Type DEVICE

Intraoperative warming

II

Intraoperative warming by HotDog

Group Type ACTIVE_COMPARATOR

Intraoperative warming (HotDog)

Intervention Type DEVICE

Intraoperative warming

Interventions

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Intraoperative warming (Bair Hugger)

Intraoperative warming

Intervention Type DEVICE

Pre- and intraoperative warming (HotDog)

Pre- and intraoperative warming by HotDog

Intervention Type DEVICE

Intraoperative warming (HotDog)

Intraoperative warming

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Christa Boer

Prof.dr. C. Boer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christa Boer, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, , Netherlands

Site Status

Spaarne Ziekenhuis

Hoofddorp, , Netherlands

Site Status

Isala Klinieken

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2007/235

Identifier Type: -

Identifier Source: org_study_id