Effect of PEEP on Intraoperative Hypothermia
Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study
調査の概要
詳細な説明
It is well known that intraoperative hypothermia is associated with postoperative adverse clinical outcomes in various study populations. Intraoperative hypothermia has various adverse effects including impaired drug clearance, cold diuresis and hypovolemia, immunosuppression with increased infection risk, electrolyte disorders, coagulopathy with impaired platelet function, negative nitrogen balance, shivering, insulin resistance, and myocardial events. Numerous methods have been introduced to prevent intraoperative hypothermia, such as warming of infusion fluid, forced-air warming, heat-pads, heated water mattress, and heated humidifiers. However, in patients undergoing lumbar spine surgery in the prone position, these methods to prevent intraoperative hypothermia may partially effective because these methods, in clinical practice, have a significant limitation in their application.
Positive end-expiratory pressure (PEEP) reduces the venous return by increasing intrathoracic pressure. This causes carotid unloading, which leads to a secondary peripheral vasoconstriction by increasing thermoregulatory vasoconstriction threshold and blunts intraoperative hypothermia. Previous studies demonstrated that intraoperative PEEP significantly attenuated the extent of intraoperative hypothermia in patients undergoing tympanoplasty. However, the beneficial effect of PEEP on thermoregulation is not investigated in patients with the prone position for spinal surgery.
The investigators hypothesized that PEEP can reduce the extent of intraoperative hypothermia via thermoregulatory modulation. In this study, the investigators investigated the effect of PEEP on intraoperative core body temperature and the incidence of intraoperative hypothermia in patients undergoing spinal surgery
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Seoul、大韓民国、110-799
- Seoul National University of Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients who were scheduled for elective spine surgery requiring more than 3 hours
Exclusion Criteria:
- Patients who do not agree to the study
- Patients with or American Society of Anesthesiologists (ASA) physical status class 3 or more
- Patients with thyroid disease, peripheral vascular diseases, uncontrolled diabetes or hypertension
- Patients with morbid obesity (BMI >35 kg/m2)
- Patients with clinically severe pulmonary disease
- Patients undergoing simultaneous anterior and posterior lumbar fusion surgery were also excluded.
- Patients with taking non-steroidal anti-inflammatory drug within two weeks
- Patients with preoperative fever or hypothermia
- Patients with intraoperative intentional hypothermia for neuroprotection
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Group P
Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively
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application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation
他の名前:
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介入なし:Group C
Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively
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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 |
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Body temperature as assessed by esophageal temperature probe
時間枠:180 minutes after the completion of anesthesia induction
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Body temperature is assessed by esophageal temperature probe.
The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome
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180 minutes after the completion of anesthesia induction
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Thermoregulatory vasoconstriction threshold
時間枠:until 180 minutes after the completion of anesthesia induction
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The time of the difference in skin temperature between forearm and fingertip becoming zero.
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until 180 minutes after the completion of anesthesia induction
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Yamasaki H, Tanaka K, Funai Y, Suehiro K, Ikenaga K, Mori T, Osugi H, Nishikawa K. The impact of intraoperative hypothermia on early postoperative adverse events after radical esophagectomy for cancer: a retrospective cohort study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):943-7. doi: 10.1053/j.jvca.2014.02.013.
- Nakajima Y, Mizobe T, Takamata A, Tanaka Y. Baroreflex modulation of peripheral vasoconstriction during progressive hypothermia in anesthetized humans. Am J Physiol Regul Integr Comp Physiol. 2000 Oct;279(4):R1430-6. doi: 10.1152/ajpregu.2000.279.4.R1430.
- Jung KT, Kim SH, Lee HY, Jung JD, Yu BS, Lim KJ, So KY, Lee JY, An TH. Effect on thermoregulatory responses in patients undergoing a tympanoplasty in accordance to the anesthetic techniques during PEEP: a comparison between inhalation anesthesia with desflurane and TIVA. Korean J Anesthesiol. 2014 Jul;67(1):32-7. doi: 10.4097/kjae.2014.67.1.32. Epub 2014 Jul 29.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
脊椎疾患の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル
PEEPの臨床試験
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University Hospital, Basel, Switzerland募集
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Pontificia Universidad Catolica de ChileClínica Universidad de los Andes募集
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Ludhmila Abrahão HajjarUniversity of Sao Pauloわからない
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Universitätsklinikum Köln引きこもった
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University of Alabama at Birmingham募集気管支肺異形成 | 換気灌流の不一致 | 人工呼吸器肺;新生児 | 極度の未熟児 | 肺疾患および低酸素による肺高血圧症アメリカ
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University Hospital, Angers募集