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

Completed

• Conditions: Monitored Anesthesia Care; Sedation Complication; EBUS Guided Transbronchial Needle Aspiration; Elderly Patients
• Interventions: Other: Modified Frailty Index -11

• Registration Number: NCT06174168
• Lead Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Modified Frailty Index -11	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.
Group 1	Modified Frailty Index -11	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.

Primary Outcome Measures

Name	Time	Method
Modified Fraility Index -11	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.

Trial Locations

Locations (1)

Ankara Atatürk Sanatoryum Hospital; 🇹🇷 Ankara, Turkey