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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
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, University of Thessaly

Brief Summary:
This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T

Condition or disease Intervention/treatment Phase
Postoperative Delirium Device: BIS Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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.
Device: BIS
The implementation of BIS monitoring




Primary Outcome Measures :
  1. Incidence of POD [ Time Frame: 1st postoperative day ]
    Assess the incidence of POD with CAM and Nu-DESC tools



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. adult patients over 60 years of age
  2. an American Society of Anesthesiologists (ASA) physical status I to III
  3. undergoing elective non cardiac surgery under general anaesthesia
  4. native speakers of the Greek language
  5. eligible to leave the post-anaesthesia care unit
  6. an expected in-hospital stay at least 24 hours following surgery

Exclusion Criteria:

  1. refused to participate or sign the informed consent form
  2. surgery or anaesthesia within the last 30 day
  3. any prior or current history involving an affliction of the central nervous system
  4. severe hearing or visual impairment
  5. psychiatric disorders
  6. a score less than 5 according the Geriatric Depression Scale (GDS-15)
  7. a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
  8. alcohol consumption less than 35 units/week
  9. drug dependence
  10. previous neuropsychological testing
  11. haemodynamical instability
  12. peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)

Information from the National Library of Medicine

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


Contacts
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Contact: Eleni Arnaoutoglou, MD, PhD +306974301352 earnaout@gmail.com
Contact: Maria Ntalouka, MD, PhD +306973688099 maria.ntalouka@icloud.com

Locations
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Greece
Univeristy of Thessaly Recruiting
Larissa, Thessaly, Greece, 41110
Contact: Eleni Arnaoutoglou, MD, PhD    2413501370    earnaout@gmail.com   
Contact: Maria Ntalouka, MD    +306973688099    maria.ntalouka@icloud.com   
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         
Sponsors and Collaborators
University of Thessaly
Investigators
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Study Chair: Eleni Arnaoutoglou, MD, PhD University of Thessaly
Principal Investigator: Maria Ntalouka, MD, PhD University Hospital of Larissa
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Responsible Party: Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT04736303    
Other Study ID Numbers: POD and BIS
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders