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Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial.
Trials 2017; 18(1):600T

Abstract

BACKGROUND

Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery. Studies have identified potentially injurious roles for cardiopulmonary bypass (CPB) and subsequent reperfusion injury. Cognitive dysfunction has also been linked to the deleterious effects of hyperoxia following ischemia-reperfusion injuries in several disease states, but there has been surprisingly little study into the role of hyperoxia in reperfusion injury after CPB. The potential for tightly regulated intraoperative normoxia to ameliorate the neurocognitive decline following cardiac surgery has not been investigated in a prospective manner. We hypothesize that the use of a protocolized management strategy aimed towards maintenance of an intraoperative normoxic level of oxygen, as opposed to hyperoxia, will reduce the incidence of POCD in older patients undergoing cardiac surgery.

METHODS/DESIGN

One hundred patients aged 65 years and older undergoing non-emergency coronary artery bypass grafting surgery on cardiopulmonary bypass will be enrolled in this prospective, randomized, controlled trial. Subjects will be randomized to receive a fraction of inspired oxygen of either 35% or 100% while under general anesthesia throughout the intraoperative period. The primary outcome measure will be the incidence of POCD in the acute postoperative phase and up to 6 months. The assessment of neurocognition will be undertaken by trained personnel, blinded to study group, with the telephone Montreal Cognitive Assessment (t-MoCA) tool. Secondary outcome measures will include assessment of delirium using the Confusion Assessment Method (CAM and CAM-ICU), as well as time to extubation, days of mechanical ventilation, length of ICU and hospital stay and mortality at 6 months. With the aim of later identifying mechanistic aspects of the effect of oxygen tension, blood, urine, and atrial tissue specimens will be taken at various time points during the perioperative period and later analyzed.

DISCUSSION

This trial will be one of the first randomized controlled studies to prospectively assess the relationship between intraoperative oxygen levels and postoperative neurocognition in cardiac surgery. It addresses a promising biological avenue of intervention in this vulnerable aging population.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02591589 , registered February 13, 2015.

Authors+Show Affiliations

Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA. sshaefi@bidmc.harvard.edu.Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, 3 Blackfan Circle, Boston, MA, 02215, USA.Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.Division of Transplant Surgery, Center for Life Sciences, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29254495

Citation

Shaefi, Shahzad, et al. "Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery: Study Protocol for a Randomized Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 600.
Shaefi S, Marcantonio ER, Mueller A, et al. Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2017;18(1):600.
Shaefi, S., Marcantonio, E. R., Mueller, A., Banner-Goodspeed, V., Robson, S. C., Spear, K., ... Subramaniam, B. (2017). Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial. Trials, 18(1), p. 600. doi:10.1186/s13063-017-2337-1.
Shaefi S, et al. Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery: Study Protocol for a Randomized Controlled Trial. Trials. 2017 Dec 19;18(1):600. PubMed PMID: 29254495.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial. AU - Shaefi,Shahzad, AU - Marcantonio,Edward R, AU - Mueller,Ariel, AU - Banner-Goodspeed,Valerie, AU - Robson,Simon C, AU - Spear,Kyle, AU - Otterbein,Leo E, AU - O'Gara,Brian P, AU - Talmor,Daniel S, AU - Subramaniam,Balachundhar, Y1 - 2017/12/19/ PY - 2017/02/13/received PY - 2017/10/25/accepted PY - 2017/12/20/entrez PY - 2017/12/20/pubmed PY - 2018/8/1/medline KW - Cardiac surgery KW - Confusion Assessment Method KW - Coronary artery bypass grafting KW - Delirium KW - Hyperoxemia KW - Hyperoxia KW - Montreal Cognitive Assessment KW - Neurocognition KW - Normoxia KW - Oxygen therapy SP - 600 EP - 600 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery. Studies have identified potentially injurious roles for cardiopulmonary bypass (CPB) and subsequent reperfusion injury. Cognitive dysfunction has also been linked to the deleterious effects of hyperoxia following ischemia-reperfusion injuries in several disease states, but there has been surprisingly little study into the role of hyperoxia in reperfusion injury after CPB. The potential for tightly regulated intraoperative normoxia to ameliorate the neurocognitive decline following cardiac surgery has not been investigated in a prospective manner. We hypothesize that the use of a protocolized management strategy aimed towards maintenance of an intraoperative normoxic level of oxygen, as opposed to hyperoxia, will reduce the incidence of POCD in older patients undergoing cardiac surgery. METHODS/DESIGN: One hundred patients aged 65 years and older undergoing non-emergency coronary artery bypass grafting surgery on cardiopulmonary bypass will be enrolled in this prospective, randomized, controlled trial. Subjects will be randomized to receive a fraction of inspired oxygen of either 35% or 100% while under general anesthesia throughout the intraoperative period. The primary outcome measure will be the incidence of POCD in the acute postoperative phase and up to 6 months. The assessment of neurocognition will be undertaken by trained personnel, blinded to study group, with the telephone Montreal Cognitive Assessment (t-MoCA) tool. Secondary outcome measures will include assessment of delirium using the Confusion Assessment Method (CAM and CAM-ICU), as well as time to extubation, days of mechanical ventilation, length of ICU and hospital stay and mortality at 6 months. With the aim of later identifying mechanistic aspects of the effect of oxygen tension, blood, urine, and atrial tissue specimens will be taken at various time points during the perioperative period and later analyzed. DISCUSSION: This trial will be one of the first randomized controlled studies to prospectively assess the relationship between intraoperative oxygen levels and postoperative neurocognition in cardiac surgery. It addresses a promising biological avenue of intervention in this vulnerable aging population. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02591589 , registered February 13, 2015. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29254495/Intraoperative_oxygen_concentration_and_neurocognition_after_cardiac_surgery:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2337-1 DB - PRIME DP - Unbound Medicine ER -