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Completed

NCT Number: NCT06174168

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Atatürk Sanatoryum Hospital

Ankara, 06280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Modified Frailty Index -11

Other

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.

Other names: MFI-11

Primary outcomes

  1. Modified Fraility Index -11

    Time frame: Preoperative 1 time

    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. 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.

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Mar 5, 2024

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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