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

Hypothermia; Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03878901
• Other study ID #: Hypothermia2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2019
• Source: Peking Union Medical College Hospital
• Contact: Jiaxin Lang, doctor
• Phone: 13611119094
• Email: langjx09[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: August 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age=18 Core temperature preoperation =36.0 ? and =37.5? ASA I-III Informed consent

Exclusion Criteria:

• 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

• 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%

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia

Intervention

Combination Product:
• high risk warm
Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming
• moderate risk warm
30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation
• low risk warm
30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation

Other:
• passive warming
cotton blanket warming through operation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Hospital, Xuanwu Hospital, Beijing

References & Publications (3)

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 — View Citation

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. — View Citation

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 Pred — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative hypothermia	Core temperature<36?	During operation
Secondary	The amount of Intraoperative blood loss/blood transfusion		During operation
Secondary	Length of stay in PACU		Postoperative during in postanaesthesia care unit, up to 24 hours after surgery
Secondary	The incidence of Surgical site infection		WIthin 30 days postoperative
Secondary	Lenght of Stay in hospital		impatient period, up to 6 month after surgery
Secondary	Lenght of Stay in ICU		impatient period, up to 6 month after surgery
Secondary	Incidence of Adverse cardiovascular events		WIthin 6 month post operation
Secondary	Incidence of shiver		during in postanaesthesia care unit, up to 24 hours after surgery
Secondary	Mini-Mental State Examination (MMSE),	It's a scare to evaluate cognitive function. Total score is 30 . Higher values represent a better cognitive function.	One day preoperation and 1 , 7,30 days postoperation
Secondary	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.	One day preoperation and 1 , 7,30 days postoperation
Secondary	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.	One day preoperation and 1 , 7,30 days postoperation
Secondary	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.	One day preoperation and 1 , 7,30 days postoperation
Secondary	digit span test.	a memory test that involves remember a series of numbers test short time memory Higher values represent a better memory functions.	One day preoperation and 1 , 7,30 days postoperation
Secondary	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	One day preoperation and 1 , 7,30 days postoperation