Different Frailty Scores to Incidence of Post-operative Delirium and Cognitive Dysfunction

NCT04056871 | Completed

• 1 other identifier: U1111-1237-9788
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD). So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.

Conditions

Frail Elderly Syndrome; Postoperative Delirium; Postoperative Cognitive Dysfunction

Keywords

post-operative delirium; post-operative cognitive dysfunction; frailty; nutritional status; depression

Outcome Measures

Primary Outcomes (3)

• Occurence of confusion using Confusion Assessment Method (CAM) scores

  Delirium is present if the following are present: Feature 1-Acute Change or/and Fluctuation (any symptom) AND Feature 2-Inattention AND EITHER Feature 3-Disorganized Thinking OR Feature 4-Altered Level of Consciousness

  Within 5 days after surgery

• Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)

  Cognitive function of the patients will be assessed after discharged and must achieved post-operative day 7 with T-MOCA via phone, subsequently assessed at 1 month and 3 month later.

  Within 1 month

• Occurence of delirium using 4AT scores

  A score of 4 or more suggests delirium but is not diagnostic: more detailed assessment of mental status may be required to reach a diagnosis. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking are required. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be required depending on the clinical context.

  Within 5 days after surgery

Study Arms (2)

Fried Frailty Phenotype

This group of patients will be assess by using 5 characteristics of Frailty which are weight loss, weakness, exhaustion, low activity and physical fitness of the patients. Patients classify as frail will have more than 3 criteria, intermediate or pre-frail will be 1 or 2 criteria present and robust will not have criteria.

Diagnostic Test: Frailty Screening Tools

Groningen Frailty Index

GFI is a simple questionnaire consisting of 15 items which are classified into 8 groups, consistent of 4 domains of functioning. A score of 4 or more indicates a higher risk for frailty and possible delirium.

Diagnostic Test: Frailty Screening Tools

Interventions

Frailty Screening Tools DIAGNOSTIC_TEST

This is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given.

Fried Frailty Phenotype; Groningen Frailty Index

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients above 65 years of age undergoing elective surgery under anesthetic care for both general and regional anesthesia with or without sedation.

You may qualify if:

• Age 65 years old and above
• ASA 1 - 3
• Full GCS
• Elective surgery
• Able to communicate well
• Consented
• Extubated at the end of surgery

You may not qualify if:

• Cardiac and neurosurgery
• On drugs affecting the central nervous system
• Admission to ICU intubated to continue ventilation.
• Refusal of consent
• Severe hearing loss
• Unable to use telephone/ mobile phone for communication

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (53)

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MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Frailty; Depression

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• Pui San Loh

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 14, 2019
• Study Start: August 20, 2019
• Primary Completion: January 30, 2020
• Study Completion: February 20, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

MY (1)