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Optimizing Postoperative Cognition the Elderly

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Icahn School of Medicine at Mount Sinai
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02650687
First received: December 23, 2015
Last updated: July 7, 2016
Last verified: July 2016
  Purpose
This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. The hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.

Condition Intervention
Postoperative Cognitive Dysfunction
POCD
Procedure: Processed EEG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimizing Postoperative Cognition the Elderly

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • UDS battery [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

  • UDS battery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition


Secondary Outcome Measures:
  • Processed EEG [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Processed EEG will be measured using the Bispectral Index (BIS) monitor.

  • CAM-ICU [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  • CAM-ICU [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  • CAM-ICU [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  • CAM-ICU [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  • PQRS [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  • PQRS [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  • PQRS [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  • PQRS [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)


Estimated Enrollment: 175
Study Start Date: October 2015
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elective Non Cardiac Surgical Patients
65 years of age and older
Procedure: Processed EEG
In the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care.
Other Name: brain waves

Detailed Description:

Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai. After informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. In the recovery room the Post Anesthesia Recovery Scale (PQRS), and CAM-ICU delirium screening will be administered. Immediate recovery will be recorded using the Postoperative Recovery Scale (PQRS) on postoperative day 1 and 3, and 1 week.

Longterm functional recovery will be measured with the Alzheimer's Disease Research Center (ADRC) Instrumental Activities for Daily Living (IADL-24). Postsurgical complications will be recorded including unplanned ICU admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. The full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai.
Criteria

Inclusion Criteria:

  • 65 years of age and older
  • having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay

Exclusion Criteria:

  • previous diagnosis of dementia, stroke, cardiac or intracranial surgery
  • inability to consent or communicate in English or Spanish
  • major uncorrected hearing or vision deficit, Parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02650687

Contacts
Contact: Stacie Deiner, MD, MS 212-241-7749 stacie.deiner@mountsinai.org
Contact: Dionne Bobb, MPH, MS 212-241-7749 dionne.bobb@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Stacie Deiner, MD, MS         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Investigators
Principal Investigator: Stacie Deiner, MD, MS Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02650687     History of Changes
Other Study ID Numbers: GCO 13-1692  1K23AG048332-01A1 
Study First Received: December 23, 2015
Last Updated: July 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Icahn School of Medicine at Mount Sinai:
Postoperative Cognitive Dysfunction
Elderly, geriatric
Anesthesia
Anesthetic depth
Bispectral index monitor
Function
Recovery after surgery
Surgery

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016