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

Sponsors

Lead Sponsor: Peking Union Medical College Hospital

Collaborator: Xuanwu Hospital, Beijing
Beijing Hospital

Source 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.

Overall Status Not yet recruiting
Start Date April 1, 2019
Completion Date August 31, 2021
Primary Completion Date March 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of intraoperative hypothermia During operation
Secondary Outcome
Measure 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), One day preoperation and 1 , 7,30 days postoperation
digit symbol substitution test One day preoperation and 1 , 7,30 days postoperation
Auditory Verbal Learning Test, One day preoperation and 1 , 7,30 days postoperation
Color Word Stroop Test One day preoperation and 1 , 7,30 days postoperation
digit span test. One day preoperation and 1 , 7,30 days postoperation
postoperative cognitive dysfunction incidence One day preoperation and 1 , 7,30 days postoperation
Enrollment 800
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: high risk warm

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

Arm Group Label: warm group

Intervention Type: Combination Product

Intervention Name: moderate risk warm

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

Arm Group Label: warm group

Intervention Type: Combination Product

Intervention Name: low risk warm

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

Arm Group Label: warm group

Intervention Type: Other

Intervention Name: passive warming

Description: cotton blanket warming through operation

Arm Group Label: control group

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%

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Yuguang Huang, doctor Study Chair Peking Union Medcial College Hospital
Overall Contact

Last Name: Jiaxin Lang, doctor

Phone: 13611119094

Email: [email protected]

Verification Date

March 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Peking Union Medical College Hospital

Investigator Full Name: Jie YI

Investigator Title: Vice director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: control group

Type: Sham Comparator

Description: Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation.

Label: warm group

Type: Experimental

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov