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Hypothermia; AnesthesiaNCT03878901

Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome

A study testing high risk warm, moderate risk warm and low risk warm in people with Hypothermia; Anesthesia, run by Peking Union Medical College Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, single-blinded, multi-center study clinical trial to determine both clinical and health outcomes of stratified warm strategy to prevent intraoperative hypothermia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypothermia; Anesthesia
What is being tested?
high risk warm, moderate risk warm and low risk warm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
No sites listed yet
Study dates
1 Apr 2019to 31 Aug 2021
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

  • Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent

Who cannot join

  • emergency operation
  • uncontrolled diebete mellitus with insulin treatment （preoperative blood glucose>250mg/dL）
  • hyperthyroidism and hypothyroidism
  • Raynaud's disease
  • patients with hematopathy and immune disease
  • anticoagulant and non-steroid anti-inflammatory drug intake with 14 days before operation
Show all 14Show fewer
  • infectious fever within 4 weeks before operation
  • laboratory abnomality as follow
  • Hemoglobin≤10.0g/L
  • Platelet≤100,000/ml
  • White blood cell<3000/dl or>14,000/dl
  • Fibrinogen<200mg/dL
  • Thrombin time>40 second
  • International normalized ratio<70%

Trial locations and contacts

No sites are listed yet.

Jiaxin Lang, doctor contact

13611119094

langjx09@163.com

Jie Yi, doctor contact

13701362812

neyil@pumch.cn

About this study

Official title: Establishment of Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome-a Prospective Multiple Centers Randomized Controlled Study

This is a randomized, single-blinded, multi-center study clinical trial to determine both clinical and health outcomes of stratified warm strategy to prevent intraoperative hypothermia. Participants enrolled into this trial will be from elective major surgery population in PUMC Hospital, Beijing Hospital and Xuanwu Hospital. investigators plan to enroll approximately 800 participants. Hypothermia risk will be evaluated through PREDICTOR model in all participants. According to hypothermia risk level, these participants will be stratefied into high, moderate and low risk group. Participants in each group will be randomly categorize into warm group and control group. Active warm and fluid warm strategy, prewarm and fluid warm strategy and only prewarm strategy are used for high risk, moderate risk and low risk patients seperately. For controll group traditional passive warm was used.

Being tested
high risk warm, moderate risk warm, low risk warm, passive warming
Keywords
hypothermia
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high risk warmCombination product

    Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming

  • moderate risk warmCombination product

    30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation

  • low risk warmCombination product

    30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation

  • passive warmingOther

    cotton blanket warming through operation

Study groups in NCT03878901
Study groupRoleWhat they receive
control groupSham comparatorCotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation.
Receives: Other: passive warming
warm groupExperimentalWarm according to different hypothermia risk for low risk ---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) continues throughout the entire operation. moderate risk---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) and fluid warming continues throughout the entire operation. high risk ----Forced-air warming(FAW) starts at least 30 min preoperatively, FAW and fluid warming continues throughout the entire operation.
Receives: Combination Product: high risk warm; Combination Product: moderate risk warm; Combination Product: low risk warm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intraoperative hypothermia

    Core temperature<36℃

    Measured: During operation

Secondary outcomes (13)

  1. The amount of Intraoperative blood loss/blood transfusion

    Measured: During operation

  2. Length of stay in PACU

    Measured: Postoperative during in postanaesthesia care unit， up to 24 hours after surgery

  3. The incidence of Surgical site infection

    Measured: WIthin 30 days postoperative

  4. Lenght of Stay in hospital

    Measured: impatient period， up to 6 month after surgery

  5. Lenght of Stay in ICU

    Measured: impatient period， up to 6 month after surgery

  6. Incidence of Adverse cardiovascular events

    Measured: WIthin 6 month post operation

  7. Incidence of shiver

    Measured: during in postanaesthesia care unit， up to 24 hours after surgery

  8. Mini-Mental State Examination (MMSE),

    It's a scare to evaluate cognitive function. Total score is 30 . Higher values represent a better cognitive function.

    Measured: One day preoperation and 1 , 7，30 days postoperation

  9. digit symbol substitution test

    The digit symbol substitution test is an evaluation tool used to assess cognitive functioning. It initially was part of the Wechsler Adult Intelligence Test (WAIS), a well-known test that measures an individual's attention. lower digit symbol test scores were correlated with a higher risk of developing dementia in both the five and 10 year groups.Higher values represent a better cognitive function.

    Measured: One day preoperation and 1 , 7，30 days postoperation

  10. Auditory Verbal Learning Test,

    a memory test that involves learning verbal material, usually single words presented in a list, that is continually presented over repeated trials. Higher values represent a better memory functions.

    Measured: One day preoperation and 1 , 7，30 days postoperation

  11. Color Word Stroop Test

    The Stroop Colour and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Higher values represent a better ability to inhibit cognitive interference.

    Measured: One day preoperation and 1 , 7，30 days postoperation

  12. digit span test.

    a memory test that involves remember a series of numbers test short time memory Higher values represent a better memory functions.

    Measured: One day preoperation and 1 , 7，30 days postoperation

  13. postoperative cognitive dysfunction incidence

    • Z score=（postoperative score-preoperative core）/SD of non-surgical group
    • Two or more than two item in cognitive examination Z score<-1.96
    • Z score=（postoperative score-preoperative core）/SD of non-surgical group Two or more than two item in cognitive examination Z score<-1.96

    Measured: One day preoperation and 1 , 7，30 days postoperation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start1 Apr 2019 (estimated)
  3. Primary completion31 Mar 2021 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878901
Sponsor's protocol ID
Hypothermia2018
Status last verified
Mar 2019
First submitted
13 Mar 2019
Last updated
18 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: There is not a plan to make IPD available.

Publications

  • Yi J, Xiang Z, Deng X, Fan T, Fu R, Geng W, Guo R, He N, Li C, Li L, Li M, Li T, Tian M, Wang G, Wang L, Wang T, Wu A, Wu D, Xue X, Xu M, Yang X, Yang Z, Yuan J, Zhao Q, Zhou G, Zuo M, Pan S, Zhan L, Yao M, Huang Y. Incidence of Inadvertent Intraoperative Hypothermia and Its Risk Factors in Patients Undergoing General Anesthesia in Beijing: A Prospective Regional Survey. PLoS One. 2015 Sep 11;10(9):e0136136. doi: 10.1371/journal.pone.0136136. eCollection 2015.

    PubMed 26360773

  • Yi J, Zhan L, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Yao M, Huang Y. Establishment and Validation of a Prediction Equation to Estimate Risk of Intraoperative Hypothermia in Patients Receiving General Anesthesia. Sci Rep. 2017 Oct 24;7(1):13927. doi: 10.1038/s41598-017-12997-x.

    PubMed 29066717

  • Yi J, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Xiang Z, Pan S, Zhan L, Qiu K, Yao M, Huang Y. Intraoperative hypothermia and its clinical outcomes in patients undergoing general anesthesia: National study in China. PLoS One. 2017 Jun 8;12(6):e0177221. doi: 10.1371/journal.pone.0177221. eCollection 2017.

    PubMed 28594825

Questions about this trial

What is this clinical trial studying?

A study testing high risk warm, moderate risk warm and low risk warm in people with Hypothermia; Anesthesia, run by Peking Union Medical College Hospital.

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 1 inclusion and 14 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jiaxin Lang, doctor (13611119094, langjx09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative hypothermia (time frame: During operation). 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 NCT03878901, which also lists 3 linked publications.

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 Mar 2019.

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