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.

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.

Study Overview

• Status: Completed
• Conditions: Elderly Patients; Sedation Complication; Monitored Anesthesia Care; EBUS Guided Transbronchial Needle Aspiration
• Intervention / Treatment: Other: Modified Frailty Index -11

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 Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06280
    • Ankara Atatürk Sanatoryum Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

EBUS-TBNA planned >65 years of age, including ASA 1-3 parts. The estimated duration is expected to be three months. Patients with a body mass index over 30 kg/m2, intubation or tracheostomy, nasal or nasopharyngeal disease, communication difficulties, ASA 4-5 patients, psychiatric illnesses, and emergency diseases will be excluded from the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 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.	Other: Modified 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.; Other Names: MFI-11
Group 2; 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.	Other: Modified 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.; Other Names: MFI-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Fraility Index -11	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.	Preoperative 1 time

Collaborators and Investigators

• Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
• Investigators: Principal Investigator: İrem ULUTAŞ ORDU, M.D, Ankara Atatürk Sanatoryum Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sedation; monitored anesthesia care; elderly patients; ebus guided transbronchial needle aspiration
• Other Study ID Numbers: E-53610172-799-224037416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No