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The Decisiveness of MFI-11 in Predicting Complications in Patients > 65 Years Who Underwent EBUS-TBNA Under Sedation

Combining Modified Frailty Index 11 (MFI-11) in Predicting Complements in Patients Over 65 Years of Age Who Underwent Endobronchial Ultrasonography-guided Transbronchial Needle Aspiration (EBUS-TBNA) Under Sedation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06174168
Enrollment
101
Registered
2023-12-18
Start date
2023-10-01
Completion date
2024-02-01
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EBUS Guided Transbronchial Needle Aspiration, Elderly Patients, Monitored Anesthesia Care, Sedation Complication

Keywords

sedation, ebus guided transbronchial needle aspiration, monitored anesthesia care, elderly patients

Brief summary

The aim is to evaluate the feasibility of MFI-11, one of the comprehensive frailty tests, before EBUS-TBNA. The secondary aim is to evaluate the usefulness of MFI-11 in predicting complications in risk assessment before EBUS-TBNA.

Detailed description

Patients who will receive anesthesia are directed to the anesthesia clinic for preoperative evaluation. The primary purpose of preoperative assessment is to reduce perioperative morbidity and increase quality, reduce the cost of perioperative care, and ensure that the patient recovers as quickly as possible. In this context, the American Society of Anesthesiology (ASA) score is a classification that includes medical comorbidities. The classification system alone does not predict perioperative risks, but when combined with other factors (e.g. type of surgery, frailty) it may help predict perioperative risks. Age is not among the criteria in the ASA. In elderly patients, the indicator of decreased reserves and resulting weakness is called frailty. Frailty is considered vulnerability and functional impairment caused by a significant decline in multiple systems. Objective, repeatable, and accepted scales must be used when evaluating frailty. MFI-11 is a strong predictor of mortality and postoperative complications.

Interventions

OTHERModified Frailty Index -11

MFI-11: the parameter included in the score is history of congestive heart failure, presence of diabetes mellitus, history of chronic obstructive pulmonary disease or pneumonia, functional health status/dependence, history of hypertension, history of myocardial infarction, cardiac problems, cognitive impairment, history of transient ischemic attack or cerebrovascular accident, history of peripheral vascular disease is questioned. Patients will be monitored according to standard non-operating room anesthesia procedures.

Sponsors

Ankara Ataturk Sanatorium Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients who underwent EBUS-TBNA under sedation * Patients aged \>65 years * ASA 1-3 patients

Exclusion criteria

* Patients who did not volunteer for the study * \< 65 years old patients * ASA \> 3 patients * Patients with psychiatric illness * Intubated patients * Patients with tracheostomy * Patients with body mass index \> 30 kg/m2 * Patients with nasal and nasopharyngeal disease * Patients with drug allergies (drugs used in anesthesia)

Design outcomes

Primary

MeasureTime frameDescription
Modified Fraility Index -11Preoperative 1 timeIn elderly patients, the indicator of decreased reserves and resulting weakness is called frailty. Frailty is considered vulnerability and functional impairment caused by a significant decline in multiple systems. When evaluating frailty, objective, repeatable and accepted scales must be used. MFI-11 is a strong predictor of mortality and postoperative complications. MFI-11 is calculated by dividing the existing deficits by the total number of deficits. Each parameter is 1 point, and the MFI-11 score will be calculated by adding all the points and dividing by 11. The higher this score, the more frail the patient. As a result of studies comparing frailty, if the MFI-11 score is greater than ≥ 0.27, these patients are defined as frail.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026