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

NCT ID: NCT06174168

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-02-01

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Modified Frailty Index -11

Intervention Type: 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.

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.

Modified Frailty Index -11

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

MFI-11

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Irem Ulutas Ordu

RESEARCHER MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İrem ULUTAŞ ORDU, M.D

Role: PRINCIPAL_INVESTIGATOR

Ankara Atatürk Sanatoryum Training and Research Hospital

Locations

Ankara Atatürk Sanatoryum Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-53610172-799-224037416

Identifier Type: -

Identifier Source: org_study_id