HypothermiaHOTNCT00617136
Perioperative Temperature Management
A study testing Intraoperative warming (Bair Hugger), Pre- and intraoperative warming (HotDog) and Intraoperative warming (HotDog) in people with Hypothermia, run by Amsterdam UMC, location VUmc at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- Intraoperative warming (Bair Hugger), Pre- and intraoperative warming (HotDog) and Intraoperative warming (HotDog)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesNetherlands
- Study dates
- Apr 2008to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an elective orthopedic knee- or hip replacement
- Participation based on informed consent
- > 18 years old and < 85 years old
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Netherlands3 sites
VU University Medical Center
Amsterdam, 1081 HV
Spaarne Ziekenhuis
Hoofddorp, 2134 TM
Isala Klinieken
Zwolle
About this study
Official title: Perioperative Temperature Management: A Big Small Problem
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.
Read the 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
- Conditions
- Hypothermia
- Being tested
- Intraoperative warming (Bair Hugger), Pre- and intraoperative warming (HotDog), Intraoperative warming (HotDog)
- Keywords
- Surgery, Anesthesia, Hypothermia, Temperature, Perioperative, Temperature Management
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| III | Experimental | Prewarming by HotDog Receives: Device: Pre- and intraoperative warming (HotDog) |
| I | Active comparator | Intraoperative warming by Bair Hugger Receives: Device: Intraoperative warming (Bair Hugger) |
| II | Active comparator | Intraoperative warming by HotDog Receives: Device: Intraoperative warming (HotDog) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative hypothermia
Measured: During surgery (1 hour after start warming)
Secondary outcomes (3)
Perioperative blood loss
Measured: During surgery
Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort
Measured: During surgery
Postoperative glucose and insulin levels
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christa Boer, Amsterdam UMC, location VUmc
- Investigators
- Christa Boer, PhD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617136
- Sponsor's protocol ID
- 2007/235
- Acronym
- HOT
- Status last verified
- Dec 2014
- First submitted
- 4 Feb 2008
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Temperature Management: A Big Small Problem
- ClinicalTrials.gov ID
- NCT00617136
- Acronym / sponsor ID
- HOT / 2007/235
- Conditions
- Hypothermia
- Keywords
- Surgery, Anesthesia, Hypothermia, Temperature, Perioperative, Temperature Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| III | Experimental | Device: Pre- and intraoperative warming (HotDog)Prewarming by HotDog |
| I | Active comparator | Device: Intraoperative warming (Bair Hugger)Intraoperative warming by Bair Hugger |
| II | Active comparator | Device: Intraoperative warming (HotDog)Intraoperative warming by HotDog |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing an elective orthopedic knee- or hip replacement
- Participation based on informed consent
- > 18 years old and < 85 years old
Key exclusion criteria (7 listed)
- BMI 18.5 > x < 40
- Pregnancy
- Non elective trauma patients
- Infectious or febrile patients (> 37.5oC)
- Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative warming (Bair Hugger)Intraoperative warming | Device | I |
| Pre- and intraoperative warming (HotDog)Pre- and intraoperative warming by HotDog | Device | III |
| Intraoperative warming (HotDog)Intraoperative warming | Device | II |
Primary outcome
Incidence of perioperative hypothermia
Time frame: During surgery (1 hour after start warming)
3 secondary outcomes
Perioperative blood loss
Time frame: During surgery
Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort
Time frame: During surgery
Postoperative glucose and insulin levels
Time frame: 1 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christa Boer, PhD study chair
Amsterdam UMC, location VUmc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative warming (Bair Hugger), Pre- and intraoperative warming (HotDog) and Intraoperative warming (HotDog) in people with Hypothermia, run by Amsterdam UMC, location VUmc at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative hypothermia (time frame: During surgery (1 hour after start warming)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.