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FrailtyNCT04783662

Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients

An observational study of Frailty, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Frailty is a state of vulnerability, characterized by a loss of mechanisms that maintain homeostasis, determining a lower capacity for recovery in the event of a stressful incident. It is one of the risk factors that increase postoperative adverse outcomes in the elderly population. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Frailty
What is being tested?
Intraoperative frontal electroencephalogram
Type of treatment
Medical device
How many people
60 participants
Where
1 siteChile
Study dates
13 May 2021to 28 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients ≥ 65 years scheduled for elective non-cardiac surgery requiring general anesthesia.

Who may be able to join

  • Patients ≥ 65 years of age
  • Undergoing elective non-cardiac surgery requiring general anesthesia with Sevoflurane
  • American Society of Anesthesiologists Physical Status I to III

Who cannot join

  • Emergency surgery
  • Neurosurgical patients
  • History of alcohol
  • History of recreational psychoactive drug use
  • Allergy to anesthetic drugs.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital Clínico Pontificia Universidad Católica de Chile

    Santiago, Santiago Metropolitan, 8330024

Other trials in Chile

About this study

Official title: Study of an Intraoperative Frontal Electroencephalographic Marker of Preoperative Frailty in Patients Over 65 Years of Age for Elective Non-cardiac Surgery.

Frailty is a state of vulnerability, characterized by a loss of mechanisms that maintain homeostasis, determining a lower capacity for recovery in the event of a stressful incident. It is one of the risk factors that increase postoperative adverse outcomes in the elderly population. It has been associated with worse results in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. Currently, there are several instruments for diagnosis and screening of frailty. All of them require time for their execution, an experienced evaluator and an adequate validation in the population in which they are intended to be used. The use of frontal electroencephalography during the intraoperative period has become increasingly popular. It allows the monitoring of brain activity during the administration of anesthetics. Various intraoperative electroencephalographic markers, such as alpha spectral power or total spectrum power, have been associated with factors such as preoperative physical activity, preoperative cognitive level, comorbidities, and postoperative delirium. The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in ≥ 65 years patients undergoing general anesthesia with Sevoflurane for non-cardiac surgery.

Read the detailed description

The world health organization has estimated that the population over 60 years of age will increase exponentially between 2015 and 2050. This change will be more pronounced in developing countries, including Chile. Each year, the number of older people (≥ 65 years) undergoing surgical interventions raises. This is due to a sustained increase in life expectancy, demographic changes, and progress in surgical/anesthetic techniques that allow this population to undergo less invasive procedures. In addition, older patients have a higher risk of postoperative morbidity and mortality compared to younger people.

Frailty is one of the risk factors that increase adverse postoperative outcomes in the elderly population. It is defined as a state of vulnerability or lack of physiological reserve that is characterized by an inadequate resolution of homeostasis after a stressful event. Frailty determines that an event can generate changes in the postoperative state of dependence of these patients; causing a person who was independent prior to surgery to end up requiring assistance with their activities of daily living after it. Frailty has been associated with worse outcomes in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. In addition, preoperative frailty has also been associated with postoperative delirium.

Currently, there are several instruments for the diagnosis and screening of frailty that present good sensitivity and specificity. All of them require time for their execution, an experienced evaluator and adequate validation in the population in which they are intended to be used. Furthermore, with some instruments, specific elements may be required, for example the Handgrip dynamometer for the Fried phenotype. These conditions are not always easy to obtain in the local preoperative setting and the tools are not always adequately validated for non-English speaking populations. Moreover, there is uncertainty regarding which frailty instrument to choose among the dozens described in the literature, and there are time pressures that prevent the addition of more tests or evaluations in the preoperative clinic.

The use of frontal electroencephalography (EEG) during the intraoperative period has become increasingly popular. It is used to obtain a real-time record of brain electrical activity during administration of anesthetics. Interpreting the EEG in the time domain in real time in the operation room is challenging. Therefore, various processed EEG monitors (BIS®, SedLine®) currently clinically used, have incorporated the spectral analysis to their records. The spectrum presents the advantage to show the frequency decomposition of the EEG segment for all frequencies in a given range (usually <30 Hz) by plotting the frequency on the X axis and power on the Y axis. The accumulation of spectra over time is called spectrogram and can be presented graphically on the monitor, where the X-axis represents time, Y axis the decomposition of frequencies, and the Z bar represents the amplitude or power of the different waves. With increasing age there is a decrease in spectral power and alpha wave coherence (8-12 Hz). In addition, decreased alpha spectral power during anesthetic administration has been correlated with preoperative cognitive dysfunction. Recently, preoperative physical activity, the spectral power of the alpha wave and the entire spectral band have been associated with postoperative delirium in the cardio-surgical population. In addition, the spectral power of the alpha wave and broadband power (baseline noise) has been correlated with changes in age and patient comorbidities.

The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in a population older than 65 years undergoing general anesthesia with sevoflurane for elective non-cardiac surgery. Our hypothesis is that frail patients (determined by the FRAIL, Clinical Frailty Scale and Fried scales) undergoing general anesthesia with sevofluorane for non-cardiac surgery have a lower alpha spectral power and lower entire spectral band power of the EEG compared to patients of similar age, who are robust, undergoing the same type of surgeries.

Conditions
Frailty
Being tested
Intraoperative frontal electroencephalogram
Keywords
Frailty, Electroencephalography, Pre operative, Alpha power
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative frontal electroencephalogramDevice

    Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane

Study groups in NCT04783662
Study groupRoleWhat they receive
RobustPatients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal to 0
Receives: Device: Intraoperative frontal electroencephalogram
Pre FrailPatients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is 1 or 2
Receives: Device: Intraoperative frontal electroencephalogram
FrailPatients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal or greater than 3
Receives: Device: Intraoperative frontal electroencephalogram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electroencephalogram Alpha power

    Frontal electroencephalogram spectral power between 8 - 12 Hz

    Measured: 10 minutes after airway intubation

Secondary outcomes (7)

  1. Electroencephalogram Total power

    Frontal electroencephalogram spectral power between 0.1 - 35 Hz

    Measured: 10 minutes after airway intubation

  2. Fried Phenotype

    Frailty assessed with the Fried Phenotype, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes.

    Measured: During preoperative anesthetic visit

  3. FRAIL scale

    Frailty assessed with the FRAIL Scale, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes.

    Measured: During preoperative anesthetic visit

  4. Clinical Frailty Scale (CFS)

    Frailty assessed with CFS, minimum value: 1(Very fit) - maximum value: 9 (Terminally ill), higher scores meaning worse outcomes.

    Measured: During preoperative anesthetic visit

  5. MiniCog test

    Screening for cognitive impairment, minimum value: 0 - maximum value: 5, higher scores meaning better outcomes

    Measured: During preoperative anesthetic visit

  6. MOCA (Montreal Cognitive Assessment) test

    Cognitive evaluation using MOCA (Montreal Cognitive Assessment) test, if MiniCog is positive for cognitive impairment (MiniCog ≤ 2). Minimum value: 0 - maximum value: 30, higher scores meaning better outcomes

    Measured: During preoperative anesthetic visit, if MiniCog is positive for cognitive impairment

  7. Post Anesthesia Care Unit (PACU) Postoperative Delirium

    Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), positive or negative

    Measured: One hour after patient is admitted to PACU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start13 May 2021
  3. Primary completion1 Mar 2022
  4. Study completion28 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04783662
Sponsor's protocol ID
200927001
Status last verified
Jan 2021
First submitted
2 Mar 2021
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All data will be collected and saved in digital forms. Data may be shared with other researchers with previous authorization from the PI.

Publications

  • Soreide K, Wijnhoven BP. Surgery for an ageing population. Br J Surg. 2016 Jan;103(2):e7-9. doi: 10.1002/bjs.10071. No abstract available.

    PubMed 26771471

  • Fowler AJ, Abbott TEF, Prowle J, Pearse RM. Age of patients undergoing surgery. Br J Surg. 2019 Jul;106(8):1012-1018. doi: 10.1002/bjs.11148. Epub 2019 May 22.

    PubMed 31115918

  • Norris CM, Close JCT. Prehabilitation for the Frailty Syndrome: Improving Outcomes for Our Most Vulnerable Patients. Anesth Analg. 2020 Jun;130(6):1524-1533. doi: 10.1213/ANE.0000000000004785.

    PubMed 32384342

  • Deiner S, Westlake B, Dutton RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr Soc. 2014 May;62(5):829-35. doi: 10.1111/jgs.12794. Epub 2014 Apr 14.

    PubMed 24731176

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PubMed 23395245

  • Panayi AC, Orkaby AR, Sakthivel D, Endo Y, Varon D, Roh D, Orgill DP, Neppl RL, Javedan H, Bhasin S, Sinha I. Impact of frailty on outcomes in surgical patients: A systematic review and meta-analysis. Am J Surg. 2019 Aug;218(2):393-400. doi: 10.1016/j.amjsurg.2018.11.020. Epub 2018 Nov 27.

    PubMed 30509455

  • Brown CH 4th, Max L, LaFlam A, Kirk L, Gross A, Arora R, Neufeld K, Hogue CW, Walston J, Pustavoitau A. The Association Between Preoperative Frailty and Postoperative Delirium After Cardiac Surgery. Anesth Analg. 2016 Aug;123(2):430-5. doi: 10.1213/ANE.0000000000001271.

    PubMed 27096563

  • Mahanna-Gabrielli E, Zhang K, Sieber FE, Lin HM, Liu X, Sewell M, Deiner SG, Boockvar KS. Frailty Is Associated With Postoperative Delirium But Not With Postoperative Cognitive Decline in Older Noncardiac Surgery Patients. Anesth Analg. 2020 Jun;130(6):1516-1523. doi: 10.1213/ANE.0000000000004773.

    PubMed 32384341

  • Watt J, Tricco AC, Talbot-Hamon C, Pham B, Rios P, Grudniewicz A, Wong C, Sinclair D, Straus SE. Identifying Older Adults at Risk of Delirium Following Elective Surgery: A Systematic Review and Meta-Analysis. J Gen Intern Med. 2018 Apr;33(4):500-509. doi: 10.1007/s11606-017-4204-x. Epub 2018 Jan 26.

    PubMed 29374358

  • McIsaac DI, Harris EP, Hladkowicz E, Moloo H, Lalu MM, Bryson GL, Huang A, Joanisse J, Hamilton GM, Forster AJ, van Walraven C. Prospective Comparison of Preoperative Predictive Performance Between 3 Leading Frailty Instruments. Anesth Analg. 2020 Jul;131(1):263-272. doi: 10.1213/ANE.0000000000004475.

    PubMed 31569165

  • Gleason LJ, Benton EA, Alvarez-Nebreda ML, Weaver MJ, Harris MB, Javedan H. FRAIL Questionnaire Screening Tool and Short-Term Outcomes in Geriatric Fracture Patients. J Am Med Dir Assoc. 2017 Dec 1;18(12):1082-1086. doi: 10.1016/j.jamda.2017.07.005. Epub 2017 Aug 31.

    PubMed 28866353

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

  • Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.

    PubMed 22836700

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PubMed 16129869

  • Darvall JN, Loth J, Bose T, Braat S, De Silva A, Story DA, Lim WK. Accuracy of the Clinical Frailty Scale for perioperative frailty screening: a prospective observational study. Can J Anaesth. 2020 Jun;67(6):694-705. doi: 10.1007/s12630-020-01610-x. Epub 2020 Mar 3.

    PubMed 32128722

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electroencephalogram Alpha power (time frame: 10 minutes after airway intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04783662, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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