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Completed

NCT Number: NCT04056871

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

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.

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Key information

About this study

Increasing life expectancy has led to increase in elderly populations, thus the elderly patients amounting for greater proportion of surgical cases. But, most of them are frail with multiple co-morbidities and are exposed to adverse outcome post-operatively. The commonest adverse outcomes is post-operative delirium (POD) in which clinicians often miss and often take lightly. If it is not treated, it will progress to post-operative cognitive dysfunction (POCD).

So, it is crucial to identify the risk factors pre-operatively to minimize the risk of POD and POCD. The frail patients are more likely to have pre-existing cognitive impairment with reduced cognitive reserve, hence, they are the most vulnerable to POCD and POD. One of the most commonly used frailty screening tools is Fried Frailty criteria which is an easily accessible tool that mainly screens and scores the patients physically. However, the investigators propose to use the Groningen Frailty scale as it can assess the patients in a more holistic approach, not only in physical, but also vision, heating, nutritional, co-morbidities, cognition, psychosocial and mobility of the patients.

Method:

Elderly patients >65 years old undergoing elective surgery under general or local anaesthesia in University Malaya Medical Centre will be recruited for this study, over a 6 months period from August 2019 to January 2020. Patients will be assessed with baseline cognitive assessment, nutritional status, psychological status, and frailty scores prior to the surgery. After the operation, patients will be assessed using 4AT and CAM for at least 5 days or until patients discharged. Cognitive functions will be assessed on post-operative 7th day, 1 month and 3 months with T-MOCA via phone.

All data will be analyzed using SPSS.

Impact of research:

A suitable frailty assessment tool will be identified to be used pre-operatively for elderly patients undergoing elective surgery. This tool will then be incorporated into a guideline and reference in our local setting for geriatric peri-operative management protocol.

Moreover, with the results, investigators hope to create awareness within our multidisciplinary care of elderly surgical population on frailty assessment and its correlation to post-operative delirium, cognitive dysfunction and associated poor outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Occurence of confusion using Confusion Assessment Method (CAM) scores

    Time frame: Within 5 days after surgery

    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

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

    Time frame: Within 1 month

    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.

  3. Occurence of delirium using 4AT scores

    Time frame: Within 5 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2019
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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