Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome
- Conditions
- Hypothermia; Anesthesia
- Interventions
- Combination Product: high risk warmOther: passive warmingCombination Product: moderate risk warmCombination Product: low risk warm
- Registration Number
- NCT03878901
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description warm group high risk warm Warm 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. warm group moderate risk warm Warm 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. control group passive warming Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation. warm group low risk warm Warm 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.
- Primary Outcome Measures
Name Time Method Incidence of intraoperative hypothermia During operation Core temperature\<36℃
- Secondary Outcome Measures
Name Time Method Length of stay in PACU Postoperative during in postanaesthesia care unit， up to 24 hours after surgery digit span test. One day preoperation and 1 , 7，30 days postoperation a memory test that involves remember a series of numbers test short time memory Higher values represent a better memory functions.
Lenght of Stay in hospital impatient period， up to 6 month after surgery Incidence of Adverse cardiovascular events WIthin 6 month post operation Mini-Mental State Examination (MMSE), One day preoperation and 1 , 7，30 days postoperation It's a scare to evaluate cognitive function. Total score is 30 . Higher values represent a better cognitive function.
Incidence of shiver during in postanaesthesia care unit， up to 24 hours after surgery Auditory Verbal Learning Test, One day preoperation and 1 , 7，30 days postoperation 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.
The amount of Intraoperative blood loss/blood transfusion During operation The incidence of Surgical site infection WIthin 30 days postoperative Lenght of Stay in ICU impatient period， up to 6 month after surgery digit symbol substitution test One day preoperation and 1 , 7，30 days postoperation 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.
Color Word Stroop Test One day preoperation and 1 , 7，30 days postoperation 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.
postoperative cognitive dysfunction incidence One day preoperation and 1 , 7，30 days postoperation * 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