Clinical trial NCT03878901: Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome
Official title: Establishment of Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome-a Prospective Multiple Centers Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia; Anesthesia
Keywords: hypothermia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Beijing Hospital
First posted: 2019-03-18
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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%

Primary outcomes:
measure: Incidence of intraoperative hypothermia
timeFrame: During operation
Secondary outcomes:
measure: The amount of Intraoperative blood loss/blood transfusion
timeFrame: During operation
measure: Length of stay in PACU
timeFrame: Postoperative during in postanaesthesia care unit， up to 24 hours after surgery
measure: The incidence of Surgical site infection
timeFrame: WIthin 30 days postoperative
measure: Lenght of Stay in hospital
timeFrame: impatient period， up to 6 month after surgery
measure: Lenght of Stay in ICU
timeFrame: impatient period， up to 6 month after surgery
measure: Incidence of Adverse cardiovascular events
timeFrame: WIthin 6 month post operation
measure: Incidence of shiver
timeFrame: during in postanaesthesia care unit， up to 24 hours after surgery
measure: Mini-Mental State Examination (MMSE),
timeFrame: One day preoperation and 1 , 7，30 days postoperation
measure: digit symbol substitution test
timeFrame: One day preoperation and 1 , 7，30 days postoperation
measure: Auditory Verbal Learning Test,
timeFrame: One day preoperation and 1 , 7，30 days postoperation
measure: Color Word Stroop Test
timeFrame: One day preoperation and 1 , 7，30 days postoperation
measure: digit span test.
timeFrame: One day preoperation and 1 , 7，30 days postoperation
measure: postoperative cognitive dysfunction incidence
timeFrame: One day preoperation and 1 , 7，30 days postoperation
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medcial College Hospital
name: Yuguang Huang, doctor
role: STUDY_CHAIR
References:
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.
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 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.
citation: 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.