Clinical trial NCT06174168: The Decisiveness of MFI-11 in Predicting Complications in Patients > 65 Years Who Underwent EBUS-TBNA Under Sedation
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-18
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Modified Fraility Index -11
timeFrame: Preoperative 1 time
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatoryum Hospital
Study officials:
affiliation: Ankara Atatürk Sanatoryum Training and Research Hospital
name: İrem ULUTAŞ ORDU, M.D
role: PRINCIPAL_INVESTIGATOR
References: