C ognitive O utcomes in the P ragmatic I nvestigation of optima L O xygen T argets (CO-PILOT) trial: protocol and statistical analysis plan.

Autor:	Mart MF; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA matthew.f.mart@vumc.org.; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Geriatric Research, Education, and Clinical Center (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA., Semler MW; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Bernard G; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, Tennessee, USA., Casey JD; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Ely EW; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Geriatric Research, Education, and Clinical Center (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA., Freundlich R; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Jackson JC; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Geriatric Research, Education, and Clinical Center (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA., Kiehl A; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Geriatric Research, Education, and Clinical Center (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA., Jenkins C; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Wang G; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Lindsell C; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Bryant P; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Geriatric Research, Education, and Clinical Center (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA., Rice TW; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Self WH; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Stollings J; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Wanderer JP; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Wang L; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Han JH; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Geriatric Research, Education, and Clinical Center (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA.; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Nov 01; Vol. 12 (11), pp. e064517. Date of Electronic Publication: 2022 Nov 01.
DOI:	10.1136/bmjopen-2022-064517
Abstrakt:	Introduction: Long-term cognitive impairment is one of the most common complications of critical illness among survivors who receive mechanical ventilation. Recommended oxygen targets during mechanical ventilation vary among international guidelines. Different oxygen targets during mechanical ventilation have the potential to alter long-term cognitive function due to cerebral hypoxemia or hyperoxemia. Whether higher, intermediate or lower SpO 2 targets are associated with better cognitive function at 12-month follow-up is unknown. Methods and Analysis: The P ragmatic I nvestigation of optima L O xygen T argets (PILOT) trial is an ongoing pragmatic, cluster-randomised, cluster-crossover trial comparing the effect of a higher SpO 2 target (target 98%, goal range 96%-100%), an intermediate SpO 2 target (target 94%, goal range 92%-96%) and a lower SpO 2 target (target 90%, goal range 88%-92%) on clinical outcomes in mechanically ventilated patients admitted to the medical intensive care unit at a single centre in the USA. For this ancillary study of long-term C ognitive O utcomes (CO-PILOT), survivors of critical illness who are in the PILOT trial and who do not meet exclusion criteria for CO-PILOT are approached for consent. The anticipated number of patients for whom assessment of long-term cognition will be performed in CO-PILOT is 612 patients over 36 months of enrolment. Cognitive, functional and quality of life assessments are assessed via telephone interview at approximately 12 months after enrolment in PILOT. The primary outcome of CO-PILOT is the telephone version of the Montreal Cognitive Assessment. A subset of patients will also complete a comprehensive neuropsychological telephone battery to better characterise the cognitive domains affected. Ethics and Dissemination: The CO-PILOT ancillary study was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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