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

A

Ankara Ataturk Sanatorium Training and Research Hospital

Status

Completed

Conditions

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

Treatments

Other: Modified Frailty Index -11

Study type

Observational

Funder types

Other

Identifiers

NCT06174168
E-53610172-799-224037416

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

101 participants in 2 patient groups

Group 1
Description:
Patients who did not develop any complication in the EBUS-TBNA. Patients may experience intraoperative complications (bleeding, hypoxemia, hypotension, arrhythmia, bronchospasm, pneumothorax, subcutaneous emphysema/mediastinal emphysema, respiratory depression), and postoperative complications (bleeding, pneumonia, respiratory failure, atelectasis, pleural effusion/empyema, pulmonary embolism, pulmonary edema). Complications that develop (such as acute respiratory distress syndrome, delirium, and mortality) will be recorded. After the procedure, any complications that may develop in the patients within 30 days will be questioned and recorded.
Treatment:
Other: Modified Frailty Index -11
Group 2
Description:
Patients who developed complications during EBUS-TBNA. Patients may experience intraoperative complications (bleeding, hypoxemia, hypotension, arrhythmia, bronchospasm, pneumothorax, subcutaneous emphysema/mediastinal emphysema, respiratory depression), and postoperative complications (bleeding, pneumonia, respiratory failure, atelectasis, pleural effusion/empyema, pulmonary embolism, pulmonary edema). Complications that develop (such as acute respiratory distress syndrome, delirium, and mortality) will be recorded. After the procedure, any complications that may develop in the patients within 30 days will be questioned and recorded.
Treatment:
Other: Modified Frailty Index -11

Trial contacts and locations

1

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Central trial contact

İrem ULUTAŞ ORDU, M.D.

Data sourced from clinicaltrials.gov

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