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This is a randomized, prospective controlled trial in patients undergoing cardiac surgery, specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen and partial pressure of arterial oxygen in the operating room and its impact on a widely-used and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the intraoperative period will have better neurocognitive function than those with maintenance of hyperoxia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoxic group | Experimental | To standardize key aspects of ventilator support, tidal volume will be set to 6-8ml/kg and PEEP levels will be set to 0-5cm H2O, allowing flexibility for provider preference. For normoxic oxygenation FiO2 will be set at 0.35 (35%) ideally to maintain PaO2 above 70mmHg (or saturations greater than or equal to 92%), and titrated up if need be to prevent potentially injurious hypoxemia (saturations below 92%). During cardiopulmonary bypass, blended air/ oxygen mixture will be titrated to arterial blood gas analysis with maintenance of PaO2 between 100mmHg and 150mmHg. |
|
| Hyperoxic group | Active Comparator | To standardize key aspects of ventilator support, tidal volume will be set to 6-8ml/kg and PEEP levels will be set to 0-5cm H2O, allowing flexibility for provider preference. For hyperoxic oxygenation FiO2 will be set at 1.0 (100%) throughout the intraoperative period, including cardiopulmonary bypass. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normoxic oxygenation | Other | FiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Telephonic-MoCA (t-MoCA) | t-MoCA will be performed baseline, daily starting POD#1 as well as at 1, 3 and 6 months post-operatively. In previous studies, testing through month 6, has been shown to accurately reflect more longitudinal follow-up. t-MoCA results are on a 22 point scale and will be used as a marker for cognitive function and has been validated. Blinded study staff trained in administering the assessments will collect the data. | Change from baseline tMoCA score through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Confusion Assessment Method for the ICU | CAM and CAM-ICU as a marker of delirium post-operatively will be administered and measured at the same time as the t-MoCA. This is a validated test to measure delirium. There is much data to support an increased reduction in cognitive ability in patients exhibiting post-operative delirium. | Post-operative day 1 through discharge from hospital (3-5 days on average) |
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Inclusion Criteria:
Exclusion Criteria:
Cessation Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Shahzad Shaefi, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21606393 | Background | Kilgannon JH, Jones AE, Parrillo JE, Dellinger RP, Milcarek B, Hunter K, Shapiro NI, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Relationship between supranormal oxygen tension and outcome after resuscitation from cardiac arrest. Circulation. 2011 Jun 14;123(23):2717-22. doi: 10.1161/CIRCULATIONAHA.110.001016. Epub 2011 May 23. | |
| 20516417 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 5, 2021 | |
| Reset | May 27, 2021 | |
| Release | Oct 29, 2025 | |
| Reset | Nov 13, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2021 | May 27, 2021 | |||
| Oct 29, 2025 |
| ID | Term |
|---|---|
| D018496 | Hyperoxia |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
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| Hyperoxic oxygenation | Other | FiO2 set at 1.0 throughout the procedure |
|
| Days of mechanical ventilation | Post-operative day 1 through discharge from hospital (3-5 days on average) |
| Length of stay in hospital | Post-operative day 1 through discharge from hospital (3-5 days on average) |
| Time to extubation | Post-operative day 1 through discharge from hospital |
| Patient mortality | 30 days and 6 months post-operatively |
| Biomarkers of oxidative stress, IL-6, IL-8 and others | Intraoperatively at cardiopulmonary bypass (CPB) |
| Kilgannon JH, Jones AE, Shapiro NI, Angelos MG, Milcarek B, Hunter K, Parrillo JE, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Association between arterial hyperoxia following resuscitation from cardiac arrest and in-hospital mortality. JAMA. 2010 Jun 2;303(21):2165-71. doi: 10.1001/jama.2010.707. |
| 21385416 | Background | Bellomo R, Bailey M, Eastwood GM, Nichol A, Pilcher D, Hart GK, Reade MC, Egi M, Cooper DJ; Study of Oxygen in Critical Care (SOCC) Group. Arterial hyperoxia and in-hospital mortality after resuscitation from cardiac arrest. Crit Care. 2011;15(2):R90. doi: 10.1186/cc10090. Epub 2011 Mar 8. |
| 19866506 | Background | Trzeciak S, Jones AE, Kilgannon JH, Milcarek B, Hunter K, Shapiro NI, Hollenberg SM, Dellinger P, Parrillo JE. Significance of arterial hypotension after resuscitation from cardiac arrest. Crit Care Med. 2009 Nov;37(11):2895-903; quiz 2904. doi: 10.1097/ccm.0b013e3181b01d8c. |
| 22127482 | Background | Eastwood G, Bellomo R, Bailey M, Taori G, Pilcher D, Young P, Beasley R. Arterial oxygen tension and mortality in mechanically ventilated patients. Intensive Care Med. 2012 Jan;38(1):91-8. doi: 10.1007/s00134-011-2419-6. Epub 2011 Nov 30. |
| 22226734 | Background | Pilcher J, Weatherall M, Shirtcliffe P, Bellomo R, Young P, Beasley R. The effect of hyperoxia following cardiac arrest - A systematic review and meta-analysis of animal trials. Resuscitation. 2012 Apr;83(4):417-22. doi: 10.1016/j.resuscitation.2011.12.021. Epub 2012 Jan 5. |
| 21415737 | Background | Neumar RW. Optimal oxygenation during and after cardiopulmonary resuscitation. Curr Opin Crit Care. 2011 Jun;17(3):236-40. doi: 10.1097/MCC.0b013e3283454c8c. |
| 22971589 | Background | Janz DR, Hollenbeck RD, Pollock JS, McPherson JA, Rice TW. Hyperoxia is associated with increased mortality in patients treated with mild therapeutic hypothermia after sudden cardiac arrest. Crit Care Med. 2012 Dec;40(12):3135-9. doi: 10.1097/CCM.0b013e3182656976. |
| 21722333 | Background | O'Driscoll BR, Howard LS. How to assess the dangers of hyperoxemia: methodological issues. Crit Care. 2011;15(3):435; author reply 435. doi: 10.1186/cc10272. Epub 2011 Jun 30. No abstract available. |
| 19077208 | Background | de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, Bosman RJ, de Waal RA, Wesselink R, de Keizer NF. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156. doi: 10.1186/cc7150. Epub 2008 Dec 10. |
| 22762316 | Background | Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923. |
| 23540873 | Background | Laffey JG, Talmor D. Predicting the development of acute respiratory distress syndrome: searching for the "Troponin of ARDS". Am J Respir Crit Care Med. 2013 Apr 1;187(7):671-2. doi: 10.1164/rccm.201301-0168ed. No abstract available. |
| 11172175 | Background | Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601. |
| 37535937 | Derived | Wiredu K, Mueller A, McKay TB, Behera A, Shaefi S, Akeju O. Sex Differences in the Incidence of Postoperative Delirium after Cardiac Surgery: A Pooled Analyses of Clinical Trials. Anesthesiology. 2023 Oct 1;139(4):540-542. doi: 10.1097/ALN.0000000000004656. No abstract available. |
| 29254495 | Derived | Shaefi S, Marcantonio ER, Mueller A, Banner-Goodspeed V, Robson SC, Spear K, Otterbein LE, O'Gara BP, Talmor DS, Subramaniam B. Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2017 Dec 19;18(1):600. doi: 10.1186/s13063-017-2337-1. |
| Nov 13, 2025 |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |