Cerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung Surgery
2017年2月13日 更新者：Icahn School of Medicine at Mount Sinai
Cerebral Oximetry and Recovery Following Thoracic Surgery
The current study proposes to address the question of whether patients' cerebral oxygen saturation levels are predictive of their recovery from thoracic surgery.
Further, the study poses the hypothesis that a patient's poor recovery status goes on to increase a patient's risk of developing post-operative morbidities such as pneumonia, arrhythmias and delirium.
The aim of this study is to address the observation that some patients struggle more than others in their recovery and that 1) this may be a result of intraoperative cerebral oxygen desaturations and 2) that this may affect their post-operative morbidity.
If a potential means of predicting poor outcomes is identified this will lead to further research into how to adjust the associated variables, such as cerebral oxygenation, to improve patient post-operative outcome.
調査の概要
状態
終了しました
条件
詳細な説明
Despite advances in the field of thoracic surgery, post-operative morbidity continues to be a significant problem with limited understanding of the connection between the insult of surgery and anesthesia and the pathophysiology of the development of these morbidities.
Surgeons in the thoracic department have noted that some patients seem to recover less vigorously than other patients.
What accounts for these different recovery trajectories is unclear.
Researchers have developed a Post-Operative Quality Recovery Scale (PQRS) which assesses six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient experience) and has been suggested to serve as a means of tracking patients' recovery from surgery.
研究の種類
観察的
入学 (実際)
130
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Anticipated inclusion is all patients scheduled for thoracic surgery at Mount Sinai Hospital by the aforementioned surgeons Dr. Flores and Dr. Kaufman.
Exclusion criteria will be those patients who (1) do not speak English, (2) are less that the age of 18 years old, (3) are currently prisoners, (4) do not display the capacity to consent to the trial and (5) who are unwilling to complete the study.
Screening for exclusion criteria will occur primarily in the pre-operative setting under the guidance of Drs.
Flores and Kaufman and will be reviewed by the Research Coordinator and acting anesthesiologist on the day of surgery.
説明
Inclusion Criteria:
- speak English
- 18 yo or older
- willing to participate
- undergoing thoracic surgery at Mount Sinai Hospital that will require one lung ventilation
Exclusion Criteria:
- prisoners
- lack capacity to consent to trial
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
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Exposed
Cerebral oximetry desaturation below 65% for a minimum of 3 minutes
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Not Exposed
Those patients who do not experience a cerebral oxygen desaturation below 65% for a minimum of 3 minutes
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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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Post-Operative Quality of Recovery Score (PQRS)
時間枠：up to 3 months
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Patients are assessed 30 minutes, one hour, and three hours post extubation time on day of surgery and then once daily for however long they are hospitalized up to 14 days, patients are then assessed via phone at one month and three months post-op.
Recovery is assessed via questions on multiple domains such as pain and nausea, emotional status, activities of daily living and cognitive status.
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up to 3 months
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Post-Operative Morbidity Survey (POMS) Score
時間枠：Post-Operative day 3
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The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.
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Post-Operative day 3
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Post-Operative Morbidity Survey (POMS) Score
時間枠：Post-Operative day 5
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The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.
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Post-Operative day 5
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Post-Operative Morbidity Survey (POMS) Score
時間枠：Post-Operative day 8
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The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.
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Post-Operative day 8
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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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Cognitive Assessment Method
時間枠：up to 14 days
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Also measuring delirium each day of hospitalization POD1-POD14 via modified and validated version of the CAM (Cognitive Assessment Method).
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up to 14 days
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jeffrey Silverstein, MD、Icahn School of Medicine at Mount Sinai
- スタディディレクター：Monique Roberts, BA、Icahn School of Medicine at Mount Sinai
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
- Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
- Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E376-81. doi: 10.1532/HSF98.20041062.
- Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
- Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
- Daubeney PE, Pilkington SN, Janke E, Charlton GA, Smith DC, Webber SA. Cerebral oxygenation measured by near-infrared spectroscopy: comparison with jugular bulb oximetry. Ann Thorac Surg. 1996 Mar;61(3):930-4. doi: 10.1016/0003-4975(95)01186-2.
- Hemmerling TM, Bluteau MC, Kazan R, Bracco D. Significant decrease of cerebral oxygen saturation during single-lung ventilation measured using absolute oximetry. Br J Anaesth. 2008 Dec;101(6):870-5. doi: 10.1093/bja/aen275. Epub 2008 Oct 3.
- Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
- Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.
- Ackland GL, Harris S, Ziabari Y, Grocott M, Mythen M; SOuRCe Investigators. Revised cardiac risk index and postoperative morbidity after elective orthopaedic surgery: a prospective cohort study. Br J Anaesth. 2010 Dec;105(6):744-52. doi: 10.1093/bja/aeq245. Epub 2010 Sep 28.
- Ackland GL, Moran N, Cone S, Grocott MP, Mythen MG. Chronic kidney disease and postoperative morbidity after elective orthopedic surgery. Anesth Analg. 2011 Jun;112(6):1375-81. doi: 10.1213/ANE.0b013e3181ee8456. Epub 2010 Aug 31.
- Hollowell J, Grocott MP, Hardy R, Haddad FS, Mythen MG, Raine R. Major elective joint replacement surgery: socioeconomic variations in surgical risk, postoperative morbidity and length of stay. J Eval Clin Pract. 2010 Jun;16(3):529-38. doi: 10.1111/j.1365-2753.2009.01154.x. Epub 2010 Feb 18.
- Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3.
- Grichnik KP, Ijsselmuiden AJ, D'Amico TA, Harpole DH Jr, White WD, Blumenthal JA, Newman MF. Cognitive decline after major noncardiac operations: a preliminary prospective study. Ann Thorac Surg. 1999 Nov;68(5):1786-91. doi: 10.1016/s0003-4975(99)00992-3.
- Murkin JM. Cerebral oximetry: monitoring the brain as the index organ. Anesthesiology. 2011 Jan;114(1):12-3. doi: 10.1097/ALN.0b013e3181fef5d2. No abstract available.
- Kazan R, Bracco D, Hemmerling TM. Reduced cerebral oxygen saturation measured by absolute cerebral oximetry during thoracic surgery correlates with postoperative complications. Br J Anaesth. 2009 Dec;103(6):811-6. doi: 10.1093/bja/aep309.
- Sauer AM, Kalkman C, van Dijk D. Postoperative cognitive decline. J Anesth. 2009;23(2):256-9. doi: 10.1007/s00540-009-0744-5. Epub 2009 May 15.
- Fischer GW, Benni PB, Lin HM, Satyapriya A, Afonso A, Di Luozzo G, Griepp RB, Reich DL. Mathematical model for describing cerebral oxygen desaturation in patients undergoing deep hypothermic circulatory arrest. Br J Anaesth. 2010 Jan;104(1):59-66. doi: 10.1093/bja/aep335.
- Fischer GW, Torrillo TM, Weiner MM, Rosenblatt MA. The use of cerebral oximetry as a monitor of the adequacy of cerebral perfusion in a patient undergoing shoulder surgery in the beach chair position. Pain Pract. 2009 Jul-Aug;9(4):304-7. doi: 10.1111/j.1533-2500.2009.00282.x. Epub 2009 Mar 17.
- Fischer GW, Stone ME. Cerebral air embolism recognized by cerebral oximetry. Semin Cardiothorac Vasc Anesth. 2009 Mar;13(1):56-9. doi: 10.1177/1089253208330710. Epub 2009 Jan 27.
- Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年9月1日
一次修了 (実際)
2015年9月1日
研究の完了 (実際)
2015年9月1日
試験登録日
最初に提出
2013年4月16日
QC基準を満たした最初の提出物
2013年4月17日
最初の投稿 (見積もり)
2013年4月18日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月15日
QC基準を満たした最後の更新が送信されました
2017年2月13日
最終確認日
2017年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- GCO 12-1398
- HS#: 12-00716
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