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The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium

Primary Purpose

Postoperative Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
BIS
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Univeristy of ThessalyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

POD without BIS

POD with BIS

Arm Description

Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.

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.

Outcomes

Primary Outcome Measures

Incidence of POD
Assess the incidence of POD with CAM and Nu-DESC tools

Secondary Outcome Measures

Full Information

First Posted
October 2, 2020
Last Updated
August 17, 2022
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT04736303
Brief Title
The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium
Official Title
Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POD without BIS
Arm Type
No Intervention
Arm Description
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.
Arm Title
POD with BIS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BIS
Intervention Description
The implementation of BIS monitoring
Primary Outcome Measure Information:
Title
Incidence of POD
Description
Assess the incidence of POD with CAM and Nu-DESC tools
Time Frame
1st postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients over 60 years of age an American Society of Anesthesiologists (ASA) physical status I to III undergoing elective non cardiac surgery under general anaesthesia native speakers of the Greek language eligible to leave the post-anaesthesia care unit an expected in-hospital stay at least 24 hours following surgery Exclusion Criteria: refused to participate or sign the informed consent form surgery or anaesthesia within the last 30 day any prior or current history involving an affliction of the central nervous system severe hearing or visual impairment psychiatric disorders a score less than 5 according the Geriatric Depression Scale (GDS-15) 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.) alcohol consumption less than 35 units/week drug dependence previous neuropsychological testing haemodynamical instability peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleni Arnaoutoglou, MD, PhD
Phone
+306974301352
Email
earnaout@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Ntalouka, MD, PhD
Phone
+306973688099
Email
maria.ntalouka@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, MD, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Ntalouka, MD, PhD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Thessaly
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, MD, PhD
Phone
2413501370
Email
earnaout@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Ntalouka, MD
Phone
+306973688099
Email
maria.ntalouka@icloud.com
First Name & Middle Initial & Last Name & Degree
Maria Ntalouka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Metaxia Bareka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Konstantinos Stamoulis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eleonora Stertsou, MD
First Name & Middle Initial & Last Name & Degree
Georgia Micha, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium

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