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

Sedation Complication Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06174168
• Other study ID #: E-53610172-799-224037416
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Ankara Ataturk Sanatorium Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Elderly Patients
• Monitored Anesthesia Care
• Sedation Complication

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara Atatürk Sanatoryum Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Ataturk Sanatorium Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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