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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200233
- Shanghai 6th People's Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Forced-Air Warming Group
Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period.
|
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.
|
|
アクティブコンパレータ：Routine Warming Group
Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage.
|
Routine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Inadvertent Perioperative Hypothermia
時間枠：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.
|
From anesthesia induction to 90 minutes after anesthesia completion
|
|
Perioperative Core Temperature Change
時間枠：From operating room entry to 90 minutes after anesthesia completion
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Shivering
時間枠：From the end of surgery to 24 hours postoperatively
|
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
|
|
Emergence Agitation
時間枠：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
時間枠：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
時間枠：During surgery
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Estimated blood loss recorded during the surgical procedure.
|
During surgery
|
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Postoperative Complications
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Danling Fang, RN、Shanghai 6th People's Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TKA-FAW-2018-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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