HypothermiaNCT02214524
Comparison of Active and Passive Perioperative Warming Techniques in Reducing Intraoperative Blood Loss
A study testing Bair Hugger forced air warming system in people with Hypothermia and Blood Loss,, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a randomized, open label, parallel two arm, clinical study, which compare the Bair Hugger forced-air warming blanket and the conventional warming care practice in China on patients undergoing major surgery to determine the impact of maintaining normothermia on intraoperative blood loss, requirement for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia, Blood Loss,, Blood Coagulation Disorders
- What is being tested?
- Bair Hugger forced air warming system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients≥18 years old
- Preoperative core temperature between 36.0 and 37.5°C
- American Society of Anaesthesiologists（ASA） Physical Status Classification System I-III
- No transdermal meds on the target site
- Elective major surgeries included but not limited:
- Hip replacement
- Thoracic surgery (lobectomy and esophagectomy) or abdominal surgery
Who cannot join
- Less than 18 years old
- Uncontrolled insulin-dependent diabetes mellitus (preoperative glucose >250 mg/dL)
- A preoperative temperature above 37.5°C or less than 36°C
- Hyperthyroidism and hypothyroidism
- Raynaud disease
- History of infection and fever within 4 weeks before surgery
Show all 16Show fewer
- Use of steroid or immunosuppressant within 4 weeks before surgery
- History of bleeding disorders
- Clinically significant laboratory abnormalities
- Hgb ≤ 10.0 g/L
- Platelets ≤ 100,000 / mL
- WBC（white blood cell ） <3000/dL
- Fibrinogen<200 mg/dL
- Thromboplastin time>40s
- Prothrombin time
- international normalized ratio(INR）<70%
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Jie YI, doctoral, +86 10 69152025, neyil@pumch.cn
Yuguang Huang, doctoral
About this study
Official title: Comparison of Active Warming System and Conventional Passive Warming Care in Reducing Intraoperative Blood Loss for Patients Undergoing Major Surgery
This is a randomized, open label, parallel two arm, clinical study, which compare the Bair Hugger forced-air warming blanket and the conventional warming care practice in China on patients undergoing major surgery to determine the impact of maintaining normothermia on intraoperative blood loss, requirement for transfusion of packed red blood cells and the changes of coagulation function.
Read the detailed description
Each Investigator reviews the most current Instructions for Use for Bair Hugger Forced air Warming System to assess the contraindications, warnings, and precaution sections with respect to risks and benefits for treating potential patients.
60 patients will be enrolled preliminary in this clinical trial. Equal size of 30 patients were allocated randomly into interventional or control group.
Randomization will be performed after the patient has met all eligibility criteria, including the general inclusion or exclusion and the patient or legally authorized representative has signed an informed consent form prior to any study related procedure.
Prior to induction, patients in the interventional group were provided 15 to 30 minutes forced air warming using the Bair Hugger warming unit, either in the pre-anesthesia area or OR,which may add to the total heat content of the body helping to reduce the effects of redistribution temperature drop for procedures using a temperature management strategy. The Bair Hugger warming unit is placed on its highest temperature setting and will be adjusted by the investigator depending on temperature monitoring. Temperature will be measured in both groups by either Spot-On sensor and tympanic membrane thermometer.
Statistical analysis will be performed after the data of 30 cases (both groups) were available and the sample size will be re-estimated based on preliminary data analysis. Continuous variables will be summarized with mean, median, standard deviation, minimum and maximum, as applicable. Categorical variables will be summarized with frequency and percentage. Student t test will be used to compare means for continuous variables. A Chi square test or a Fisher's exact test will be used to compare proportions for categorical variables. Multiple regression will be performed to assess the risk ratios of patients developing hypothermia and will be expressed as an risk ratio along with a 95% confidence interval.
- Conditions
- Hypothermia, Blood Loss,, Blood Coagulation Disorders
- Being tested
- Bair Hugger forced air warming system
- Keywords
- perioperative hypothermia, Tympanic temperature, Blood loss, Blood Coagulation Disorders, Major surgery
- Medical subject headings
- Hypothermia, Hemorrhage, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bair Hugger forced air warming systemDevice
Also called Bair Hugger 775, 70-2007-6800, Bair Hugger Blanket Model 635 and 300
Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery
| Study group | Role | What they receive |
|---|---|---|
| Bair hugger forced air warming therapy | Experimental | Use of Bair Hugger forced-air warming system perioperatively to keep patient normothermia Receives: Device: Bair Hugger forced air warming system |
| conventional warming care | No intervention | conventional warming care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Temperature and blood loss
Monitor the changes of core temperature for whole perioperative period and the amount of blood loss were recorded
Measured: intraoperative
Secondary outcomes (5)
Length of Stay in PACU
Measured: 90 days after Hip replacement surgery and 30 days after other surgerys
Length of Stay in Hospital
Measured: 90 days after Hip replacement surgery and 30 days after other surgerys
Length of Stay in ICU
Measured: 90 days after Hip replacement surgery and 30 days after other surgerys
Surgical Site Infection（SSI）
Measured: 90 days after Hip replacement surgery and 30 days after other surgerys
coagulation function
take blood sample to detect the coagulation function,including Prothrombin time,Active Partial Thromboplastin Time,International normalized Ratio,Thromboelastography,Hemoglobin,ect.
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Jie YI, Peking Union Medical College Hospital
- Investigators
- Yugung Huang Huang, doctoral, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214524
- Sponsor's protocol ID
- MDI0092
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yi J, Liang H, Song R, Xia H, Huang Y. Maintaining intraoperative normothermia reduces blood loss in patients undergoing major operations: a pilot randomized controlled clinical trial. BMC Anesthesiol. 2018 Sep 8;18(1):126. doi: 10.1186/s12871-018-0582-9.
PubMed 30193571
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Active Warming System and Conventional Passive Warming Care in Reducing Intraoperative Blood Loss for Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT02214524
- Acronym / sponsor ID
- MDI0092
- Conditions
- Hypothermia, Blood Loss,, Blood Coagulation Disorders
- Keywords
- perioperative hypothermia, Tympanic temperature, Blood loss, Blood Coagulation Disorders, Major surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 12 Aug 2014 (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.
This is a randomized, open label, parallel two arm, clinical study, which compare the Bair Hugger forced-air warming blanket and the conventional warming care practice in China on patients undergoing major surgery to determine the impact of maintaining normothermia on intraoperative blood loss, requirement for transfusion of packed red blood cells and the changes of coagulation function.
Detailed description
Each Investigator reviews the most current Instructions for Use for Bair Hugger Forced air Warming System to assess the contraindications, warnings, and precaution sections with respect to risks and benefits for treating potential patients.
60 patients will be enrolled preliminary in this clinical trial. Equal size of 30 patients were allocated randomly into interventional or control group.
Randomization will be performed after the patient has met all eligibility criteria, including the general inclusion or exclusion and the patient or legally authorized representative has signed an informed consent form prior to any study related procedure.
Prior to induction, patients in the interventional group were provided 15 to 30 minutes forced air warming using the Bair Hugger warming unit, either in the pre-anesthesia area or OR,which may add to the total heat content of the body helping to reduce the effects of redistribution temperature drop for procedures using a temperature management strategy. The Bair Hugger warming unit is placed on its highest temperature setting and will be adjusted by the investigator depending on temperature monitoring. Temperature will be measured in both groups by either Spot-On sensor and tympanic membrane thermometer.
Statistical analysis will be performed after the data of 30 cases (both groups) were available and the sample size will be re-estimated based on preliminary data analysis. Continuous variables will be summarized with mean, median, standard deviation, minimum and maximum, as applicable. Categorical variables will be summarized with frequency and percentage. Student t test will be used to compare means for continuous variables. A Chi square test or a Fisher's exact test will be used to compare proportions for categorical variables. Multiple regression will be performed to assess the risk ratios of patients developing hypothermia and will be expressed as an risk ratio along with a 95% confidence interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bair hugger forced air warming therapy | Experimental | Device: Bair Hugger forced air warming systemUse of Bair Hugger forced-air warming system perioperatively to keep patient normothermia |
| conventional warming care | No intervention | –conventional warming care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients≥18 years old
- Preoperative core temperature between 36.0 and 37.5°C
- American Society of Anaesthesiologists（ASA） Physical Status Classification System I-III
- No transdermal meds on the target site
- Elective major surgeries included but not limited:
Key exclusion criteria (16 listed)
- Less than 18 years old
- Uncontrolled insulin-dependent diabetes mellitus (preoperative glucose >250 mg/dL)
- A preoperative temperature above 37.5°C or less than 36°C
- Hyperthyroidism and hypothyroidism
- Raynaud disease
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 |
|---|---|---|
| Bair Hugger forced air warming systemAlso: Bair Hugger 775, 70-2007-6800, Bair Hugger Blanket Model 635 and 300Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery | Device | Bair hugger forced air warming therapy |
Primary outcome
Core Temperature and blood loss
Time frame: intraoperative
Monitor the changes of core temperature for whole perioperative period and the amount of blood loss were recorded
5 secondary outcomes
Length of Stay in PACU
Time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
Length of Stay in Hospital
Time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
Length of Stay in ICU
Time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
Surgical Site Infection（SSI）
Time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
coagulation function
Time frame: perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Derived from this study: PubMed 30193571Yi J, Liang H, Song R, Xia H, Huang Y. Maintaining intraoperative normothermia reduces blood loss in patients undergoing major operations: a pilot randomized controlled clinical trial. BMC Anesthesiol. 2018 Sep 8;18(1):126. doi: 10.1186/s12871-018-0582-9.
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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.
Yugung Huang Huang, doctoral principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bair Hugger forced air warming system in people with Hypothermia and Blood Loss,, run by Peking Union Medical College Hospital at 1 site in China.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Liang (+86 13391994260, 805582814@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature and blood loss (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214524, which also lists 1 linked publication.
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 18 Aug 2014.