Cerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung Surgery
13 février 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
130
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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New York, New York, États-Unis, 10029
- Icahn School of Medicine at Mount Sinai
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Post-Operative Quality of Recovery Score (PQRS)
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cognitive Assessment Method
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jeffrey Silverstein, MD, Icahn School of Medicine at Mount Sinai
- Directeur d'études: Monique Roberts, BA, Icahn School of Medicine at Mount Sinai
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2012
Achèvement primaire (Réel)
1 septembre 2015
Achèvement de l'étude (Réel)
1 septembre 2015
Dates d'inscription aux études
Première soumission
16 avril 2013
Première soumission répondant aux critères de contrôle qualité
17 avril 2013
Première publication (Estimation)
18 avril 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 février 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 février 2017
Dernière vérification
1 février 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- GCO 12-1398
- HS#: 12-00716
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .