Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2)
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|ClinicalTrials.gov Identifier: NCT03141619|
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : March 20, 2019
|Condition or disease|
|Critical Illness Respiratory Failure Shock Delirium|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Respiratory failure and/or shock
All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy.
- Brain tissue oxygenation and delirium [ Time Frame: 30 days ]Assessment of primary outcome: The primary hypothesis of this study is the association between BtO2 and the amount of non-comatose (i.e. RASS -4 or -5) days a patient is CAM-ICU positive (i.e. delirious). Statistical diagnostics (e.g. assessment for normality) will determine the use of parametric (Pearson) or non-parametric (Spearman's rank) correlational analysis on this data set. A correlation will be considered statistically significant if p<0.05.
- Assessment of secondary outcomes-physiological determinants of brain tissue oxygenation [ Time Frame: 72 hours ]Simultaneous multiple linear regression analysis will be used to investigate if clinically relevant hemodynamic and physiological parameters (E.g. MAP, HR, SaO2, and pCO2) predict NIRS derived BtO2.
- Brain tissue oxygenation as an independent risk factor for delirium [ Time Frame: 30 days ]To determine if BtO2 is an independent predictor of delirium, logistic regression will be used to estimate the unadjusted effect of each individual predictor on delirium duration (i.e. the number of CAM-ICU positive days). The following covariates were selected a priori, as they have been associated with delirium: a history of cognitive dysfunction, a history of hypertension, a history of alcohol abuse, MAP, blood urea nitrogen, and total narcotic dose (in fentanyl equivalents).
- Brain tissue oxygenation as an independent risk factor for long-term cognitive impairment-RBANS [ Time Frame: 3 months and 12 months ]The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be administered among ICU survivors. We will use simultaneous multiple linear regression analysis to investigate if clinical variables available on admission (e.g. history of hypertension) and data collected within the first 72 hours of the patients' ICU stay (e.g. brain tissue oxygenation) can predict participant performance on the RBANS (i.e. total score and each cognitive domain) administered at 3 and 12 month after ICU discharge.
- Brain tissue oxygenation as an independent risk factor for long-term cognitive impairment-KINARM [ Time Frame: 3 months and 12 months ]The KINARM robot will be used to assess sensorimotor and neurocognitive control of limb movements in ICU survivors. We will use simultaneous multiple linear regression analysis to investigate if clinical variables available on admission (e.g. history of hypertension) and data collected within the first 72 hours of the patients' ICU stay (e.g. brain tissue oxygenation) can predict participant performance on the KINARM (i.e. task/total score for each subtask) administered at 3 and 12 month after ICU discharge.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141619
|Contact: J. Gordon Boyd, MD, PhD||613-549-6666 ext firstname.lastname@example.org|
|Contact: Miranda Hunt||613-549-6666||huntm4@KGH.KARI.NET|
|Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L3V7|
|Contact: John G Boyd, MD, PhD 613-549-6666 ext 6228 email@example.com|
|Principal Investigator:||J. Gordon Boyd, MD, PhD||Queen's University|