Table 1 WHO Trial Registration Data Set - Structured Summary
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 |