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

NCT06174168 | Completed

• 1 other identifier: E-53610172-799-224037416
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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.

Also known as: MFI-11

Group 1; Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatoryum Hospital

Ankara, 06280, Turkey (Türkiye)

Location

Study Officials

• İrem ULUTAŞ ORDU, M.D

  Ankara Atatürk Sanatoryum Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCHER MD

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)