Clinical trial NCT02591589: Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
Official title: The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperoxia
Normoxic
Delirium
Keywords: Hyperoxia
Delirium
Normoxic
t-MoCA
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 65 years and older
* Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only

Exclusion Criteria:

* Off-pump or any other procedure in addition to CABG
* Emergent procedure
* One-lung ventilation
* Non-English speaking
* Baseline tMoCA score \<10
* Preoperative inotrope use
* Preoperative vasopressor use
* Intra-aortic balloon counterpulsation
* Mechanical circulatory support (Intra-aortic balloon pump (IABP)/ Ventricular assisted devices (VAD)/Extracorporeal membrane oxygenation (ECMO))
* Active cardiac ischemia
* Acute decompensated arrhythmia
* O2 sat \< 90% on supplemental oxygen
* Use of continuous vasopressor or inotrope infusion medications
* Significant physician or nurse concern

Cessation Criteria

* Development of significant intraoperative hemodynamic compromise as a result of cardiac surgery
* Oxygen desaturation \<90% for \> 3 min
* Significant physician or nurse concern

Primary outcomes:
measure: Telephonic-MoCA (t-MoCA)
timeFrame: Change from baseline tMoCA score through 6 months
Secondary outcomes:
measure: Confusion Assessment Method for the ICU
timeFrame: Post-operative day 1 through discharge from hospital (3-5 days on average)
measure: Days of mechanical ventilation
timeFrame: Post-operative day 1 through discharge from hospital (3-5 days on average)
measure: Length of stay in hospital
timeFrame: Post-operative day 1 through discharge from hospital (3-5 days on average)
measure: Time to extubation
timeFrame: Post-operative day 1 through discharge from hospital
measure: Patient mortality
timeFrame: 30 days and 6 months post-operatively
measure: Biomarkers of oxidative stress, IL-6, IL-8 and others
timeFrame: Intraoperatively at cardiopulmonary bypass (CPB)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Shahzad Shaefi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: Neumar RW. Optimal oxygenation during and after cardiopulmonary resuscitation. Curr Opin Crit Care. 2011 Jun;17(3):236-40. doi: 10.1097/MCC.0b013e3283454c8c.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.