Cerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung Surgery
13. februar 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
130
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Post-Operative Quality of Recovery Score (PQRS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cognitive Assessment Method
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jeffrey Silverstein, MD, Icahn School of Medicine at Mount Sinai
- Studieleder: Monique Roberts, BA, Icahn School of Medicine at Mount Sinai
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2012
Primær færdiggørelse (Faktiske)
1. september 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
16. april 2013
Først indsendt, der opfyldte QC-kriterier
17. april 2013
Først opslået (Skøn)
18. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GCO 12-1398
- HS#: 12-00716
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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