跳至主要内容
临床试验/NCT07613203
NCT07613203终止不适用

Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
240
试验地点
1

研究概览

简要总结

Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. This historical control study aims to evaluate the effectiveness and safety of intraoperative forced-air warming in preventing perioperative hypothermia in patients undergoing primary unilateral TKA.

A total of 240 patients were included. Patients in the historical control group received routine passive warming measures, while patients in the intervention group received additional forced-air warming during the perioperative period. Core body temperature, incidence of inadvertent perioperative hypothermia, anesthetic recovery outcomes, postoperative complications, and safety outcomes were evaluated.

详细描述

This single-center historical control study was conducted at Shanghai 6th People's Hospital between May 2018 and December 2018 to evaluate the effectiveness of intraoperative forced-air warming for preventing perioperative hypothermia in patients undergoing total knee arthroplasty (TKA).

A total of 240 patients undergoing primary unilateral TKA were enrolled and divided into two groups according to the study period. Patients enrolled between May 2018 and August 2018 were assigned to the historical control group and received routine passive warming measures, including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. Patients enrolled between September 2018 and December 2018 were assigned to the intervention group and received additional active warming using a forced-air warming system during the perioperative period.

The forced-air warming system was initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit (PACU). Core temperature was continuously monitored using a temperature-sensing urinary catheter.

The primary outcomes included perioperative core temperature changes and the incidence of inadvertent perioperative hypothermia, defined as core temperature below 36°C at any perioperative time point. Secondary outcomes included postoperative shivering, emergence agitation, anesthetic recovery time, blood loss, postoperative complications, and safety outcomes including skin burns and surgical site infection.

This study was approved by the Ethics Committee of Shanghai 6th People's Hospital (Approval No. 05.12.19035). Written informed consent was obtained from all participants before enrollment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

No masking was used because the forced-air warming intervention was visible to participants and care providers.

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 60 and 85 years
  • ASA physical status I or II
  • Diagnosed with knee osteoarthritis
  • Undergoing first unilateral primary total knee arthroplasty
  • Able to provide written informed consent

排除标准

  • Abnormal coagulation function (international normalized ratio >1.2)
  • Preoperative body temperature >37.5°C or <36°C
  • Cognitive or psychiatric disorders affecting communication
  • Moderate or severe anemia
  • Body mass index >30 kg/m² or <18.5 kg/m²
  • Moderate or severe malnutrition
  • Surgery duration longer than 4 hours
  • Intraoperative blood loss greater than 500 mL
  • Transfer to surgical intensive care unit after surgery

研究组 & 干预措施

Forced-Air Warming Group

Experimental

Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period.

干预措施: Forced-Air Warming (Device)

Routine Warming Group

Active Comparator

Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage.

干预措施: Routine Passive Warming (Other)

研究者

发起方
Shanghai 6th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

DanLing Fang

Principal Investigator

Shanghai 6th People's Hospital

研究点 (1)

Loading locations...

相似试验