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

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.

Study Overview

• Status: Unknown
• Conditions: Hypothermia; Anesthesia
• Intervention / Treatment: Other: passive warming; Combination product: high risk warm; Combination product: moderate risk warm; Combination product: low risk warm

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiaxin Lang, doctor; Phone Number: 13611119094; Email: langjx09@163.com
• Study Contact Backup: Name: Jie Yi, doctor; Phone Number: 13701362812; Email: neyil@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group; Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation.	Other: passive warming; cotton blanket warming through operation
Experimental: warm group; 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.	Combination product: high risk warm; Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming; Combination product: moderate risk warm; 30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation; Combination product: low risk warm; 30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypothermia	Core temperature<36℃	During operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of Intraoperative blood loss/blood transfusion		During operation
Length of stay in PACU		Postoperative during in postanaesthesia care unit， up to 24 hours after surgery
The incidence of Surgical site infection		WIthin 30 days postoperative
Lenght of Stay in hospital		impatient period， up to 6 month after surgery
Lenght of Stay in ICU		impatient period， up to 6 month after surgery
Incidence of Adverse cardiovascular events		WIthin 6 month post operation
Incidence of shiver		during in postanaesthesia care unit， up to 24 hours after surgery
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Xuanwu Hospital, Beijing; Beijing Hospital
• Investigators: Study Chair: Yuguang Huang, doctor, Peking Union Medcial College Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: hypothermia
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: Hypothermia2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No