Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty
Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200233
- Shanghai 6th People's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Forced-Air Warming Group
Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period.
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Active perioperative warming using a forced-air warming system initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit.
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활성 비교기: Routine Warming Group
Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage.
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Routine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Inadvertent Perioperative Hypothermia
기간: From anesthesia induction to 90 minutes after anesthesia completion
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The proportion of participants with core body temperature below 36.0°C at any perioperative time point.
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From anesthesia induction to 90 minutes after anesthesia completion
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Perioperative Core Temperature Change
기간: From operating room entry to 90 minutes after anesthesia completion
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Core body temperature measured using a temperature-sensing urinary catheter at predefined perioperative time points.
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From operating room entry to 90 minutes after anesthesia completion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Shivering
기간: From the end of surgery to 24 hours postoperatively
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Incidence and severity of postoperative shivering assessed using a 0-4 shivering scale.
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From the end of surgery to 24 hours postoperatively
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Emergence Agitation
기간: From 30 minutes after surgery to 2 hours postoperatively
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Incidence and severity of emergence agitation assessed using the Richmond Agitation-Sedation Scale (RASS, -5 to +4), where higher positive scores indicate greater agitation.
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From 30 minutes after surgery to 2 hours postoperatively
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Anesthetic Recovery Time
기간: From the end of anesthesia to 2 hours postoperatively
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Recovery outcomes including awakening time, extubation time, and PACU length of stay.
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From the end of anesthesia to 2 hours postoperatively
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Intraoperative Blood Loss
기간: During surgery
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Estimated blood loss recorded during the surgical procedure.
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During surgery
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Postoperative Complications
기간: From the end of surgery to 30 days postoperatively
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Incidence of postoperative complications including delirium, nausea and vomiting, cardiac adverse events, skin burns, and surgical site infection.
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From the end of surgery to 30 days postoperatively
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공동 작업자 및 조사자
수사관
- 수석 연구원: Danling Fang, RN, Shanghai 6th People's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TKA-FAW-2018-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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