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Table 1 WHO Trial Registration Data Set - Structured Summary

From: Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial

Data category Information
Primary registry, trial identifying number Clinicaltrials.gov Identifier - NCT02591589
Date of registration in primary registry February 13, 2015
Secondary identifying numbers  
Sources of monetary support Foundation for Anesthesia Education and Research Mentored Training Research Grant
Contact for public queries SS, Department of Anesthesia, Beth Israel Deaconess Medical Center, Boston MA, USA
Contact for scientific queries SS, Department of Anesthesia, Beth Israel Deaconess Medical Center, Boston MA, USA
Public title Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
Scientific title The relationship between administered oxygen levels and arterial partial oxygen pressure to neurocognition in cardiac surgical patients
Country of recruitment USA
Health problem under investigation Neurocognition after cardiac surgery
Key inclusion and exclusion criteria Age ≥ 65 years, elective or urgent coronary artery bypass surgery (CABG) on cardiopulmonary bypass (CPB)
Study type Interventional Allocation: randomized Interventional model: Masking: blinding of participant and outcomes assessor
Date of first enrollment September 2015
Target sample size 100
Recruitment status Recruiting as of January 2017
Primary outcome Change in Telephonic Montreal Cognitive Assessment from baseline up to 6 months
Key secondary outcomes Delirium incidence, time to extubation, Acute kidney injury incidence