Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

Delirium Clinical Trial

Official title:

The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02591589
• Other study ID #: 2014P000398
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Hyperoxia
• Normoxic

Intervention

Other:
• Normoxic oxygenation
FiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%.
• Hyperoxic oxygenation
FiO2 set at 1.0 throughout the procedure

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Erratum in: N Engl J Med 2001 Jun 14;344(24):1876. — View Citation

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. — View Citation

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. Review. — View 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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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)
Secondary	Days of mechanical ventilation		Post-operative day 1 through discharge from hospital (3-5 days on average)
Secondary	Length of stay in hospital		Post-operative day 1 through discharge from hospital (3-5 days on average)
Secondary	Time to extubation		Post-operative day 1 through discharge from hospital
Secondary	Patient mortality		30 days and 6 months post-operatively
Secondary	Biomarkers of oxidative stress, IL-6, IL-8 and others		Intraoperatively at cardiopulmonary bypass (CPB)