HyperoxiaNCT02591589
Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
A study testing Normoxic oxygenation and Hyperoxic oxygenation in people with Hyperoxia and Normoxic, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Normoxic oxygenation and Hyperoxic oxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Males and females aged 65 years and older
- Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
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.
- Being tested
- Normoxic oxygenation, Hyperoxic oxygenation
- Keywords
- Hyperoxia, Delirium, Normoxic, t-MoCA
- Medical subject headings
- Hyperoxia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normoxic oxygenationOther
FiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%.
Hyperoxic oxygenationOther
FiO2 set at 1.0 throughout the procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Normoxic oxygenation |
| 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. Receives: Other: Hyperoxic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline tMoCA score through 6 months
Secondary outcomes (6)
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.
Measured: Post-operative day 1 through discharge from hospital (3-5 days on average)
Days of mechanical ventilation
Measured: Post-operative day 1 through discharge from hospital (3-5 days on average)
Length of stay in hospital
Measured: Post-operative day 1 through discharge from hospital (3-5 days on average)
Time to extubation
Measured: Post-operative day 1 through discharge from hospital
Patient mortality
Measured: 30 days and 6 months post-operatively
Biomarkers of oxidative stress, IL-6, IL-8 and others
Measured: Intraoperatively at cardiopulmonary bypass (CPB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJul 2015
- Primary completion17 Jan 2018
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahzad Shaefi, Beth Israel Deaconess Medical Center
- Investigators
- Shahzad Shaefi, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591589
- Sponsor's protocol ID
- 2014P000398
- Status last verified
- Sep 2020
- First submitted
- 13 Feb 2015
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21606393Kilgannon 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.
PubMed 20516417Bellomo 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.
PubMed 21385416Trzeciak 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.
PubMed 19866506Eastwood 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.
PubMed 22127482Pilcher 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.
PubMed 22226734Neumar RW. Optimal oxygenation during and after cardiopulmonary resuscitation. Curr Opin Crit Care. 2011 Jun;17(3):236-40. doi: 10.1097/MCC.0b013e3283454c8c.
PubMed 21415737Janz 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.
PubMed 22971589O'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.
PubMed 21722333de 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.
PubMed 19077208Saczynski 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.
PubMed 22762316Laffey 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.
PubMed 23540873Newman 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.
PubMed 11172175Wiredu 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.
PubMed 37535937Shaefi 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.
PubMed 29254495
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT02591589
- Acronym / sponsor ID
- 2014P000398
- Keywords
- Hyperoxia, Delirium, Normoxic, t-MoCA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoxic group | Experimental | Other: Normoxic oxygenationTo 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 | Other: Hyperoxic oxygenationTo 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Males and females aged 65 years and older
- Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only
Key exclusion criteria (18 listed)
- Off-pump or any other procedure in addition to CABG
- Emergent procedure
- One-lung ventilation
- Non-English speaking
- Baseline tMoCA score <10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normoxic oxygenationFiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%. | Other | Normoxic group |
| Hyperoxic oxygenationFiO2 set at 1.0 throughout the procedure | Other | Hyperoxic group |
Primary outcome
Telephonic-MoCA (t-MoCA)
Time frame: Change from baseline tMoCA score through 6 months
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.
6 secondary outcomes
Confusion Assessment Method for the ICU
Time frame: Post-operative day 1 through discharge from hospital (3-5 days on average)
Days of mechanical ventilation
Time frame: Post-operative day 1 through discharge from hospital (3-5 days on average)
Length of stay in hospital
Time frame: Post-operative day 1 through discharge from hospital (3-5 days on average)
Time to extubation
Time frame: Post-operative day 1 through discharge from hospital
Patient mortality
Time frame: 30 days and 6 months post-operatively
Biomarkers of oxidative stress, IL-6, IL-8 and others
Time frame: Intraoperatively at cardiopulmonary bypass (CPB)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Background: PubMed 21606393Kilgannon 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.
- Background: PubMed 20516417Kilgannon 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.
- Background: PubMed 21385416Bellomo 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.
- Background: PubMed 19866506Trzeciak 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.
- Background: PubMed 22127482Eastwood 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.
- Background: PubMed 22226734Pilcher 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.
- Background: PubMed 21415737Neumar RW. Optimal oxygenation during and after cardiopulmonary resuscitation. Curr Opin Crit Care. 2011 Jun;17(3):236-40. doi: 10.1097/MCC.0b013e3283454c8c.
- Background: PubMed 22971589Janz 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.
- Background: PubMed 21722333O'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.
- Background: PubMed 19077208de 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.
- Background: PubMed 22762316Saczynski 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.
- Background: PubMed 23540873Laffey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahzad Shaefi, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normoxic oxygenation and Hyperoxic oxygenation in people with Hyperoxia and Normoxic, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telephonic-MoCA (t-MoCA) (time frame: Change from baseline tMoCA score through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591589, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.