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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Hypothermia; Anesthesia

Treatments: Combination Product: high risk warm; Combination Product: moderate risk warm; Combination Product: low risk warm; Other: passive warming

Study type: Interventional

Funder types: Other

Identifiers

NCT03878901

Hypothermia2018

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

control group

Sham Comparator group

Description:

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

Treatment:

Other: passive warming

warm group

Experimental group

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.

Treatment:

Combination Product: low risk warm

Combination Product: moderate risk warm

Combination Product: high risk warm