The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium
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|ClinicalTrials.gov Identifier: NCT04736303|
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : August 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Delirium||Device: BIS||Not Applicable|
This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.
The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial|
|Actual Study Start Date :||December 1, 2021|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||April 1, 2023|
No Intervention: POD without BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.
Active Comparator: POD with BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools.
The implementation of BIS monitoring
- Incidence of POD [ Time Frame: 1st postoperative day ]Assess the incidence of POD with CAM and Nu-DESC tools
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): NCT04736303
|Contact: Eleni Arnaoutoglou, MD, PhDemail@example.com|
|Contact: Maria Ntalouka, MD, PhDfirstname.lastname@example.org|
|Univeristy of Thessaly||Recruiting|
|Larissa, Thessaly, Greece, 41110|
|Contact: Eleni Arnaoutoglou, MD, PhD 2413501370 email@example.com|
|Contact: Maria Ntalouka, MD +306973688099 firstname.lastname@example.org|
|Principal Investigator: Maria Ntalouka, MD, PhD|
|Principal Investigator: Eleni Arnaoutoglou, MD, PhD|
|Sub-Investigator: Metaxia Bareka, MD, PhD|
|Sub-Investigator: Konstantinos Stamoulis, MD, PhD|
|Sub-Investigator: Eleonora Stertsou, MD|
|Sub-Investigator: Georgia Micha, MD, PhD|
|Study Chair:||Eleni Arnaoutoglou, MD, PhD||University of Thessaly|
|Principal Investigator:||Maria Ntalouka, MD, PhD||University Hospital of Larissa|