Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. The primary outcome is a ranked composite of in-hospital mortality and time to ventilator liberation. Safety and procedural adverse events are closely monitored.
Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea. Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and decline in lung function may lead to a poor prognosis and a decrease in quality of life. The purpose of bronchiectasis management is to reduce exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Bronchoscopic local instillation of gentamicin and Budesonide
Bronchoscopic local instillation of Levofloxacin and Budesonide
Bronchoscopic mechanical secretion suction and lavage
Assiut university hospitals
Asyut, Egypt
RECRUITINGDays for weaning from mechanical ventilation
days of mechanical ventilation will be measured and compared between drug and conventional groups
Time frame: one month
The amount of sputum production per day(ml/day)
The total amount of sputum per day will be measured and compared between the drug and conventional groups
Time frame: one year
6-minute walking distance (meters)
The total recorded distance in 6 minutes in meters
Time frame: one year
number of exacerbations (recorded number/year)
The number of reported exacerbations in one year
Time frame: one year
Hospital admission
The number of reported hospital admissions in one year
Time frame: one year
Quality of life assessment in bronchiectasis patients
The quality of life assessment in bronchiectasis patients using patient-reported outcome measures (Quality of Life Bronchiectasis questionnaire). It consists of 8 domains scored on a 0 - 100 scale (higher equals better QoL)
Time frame: one year
Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale
The anxiety in bronchiectasis patients will be measured using the Hamilton Anxiety rating scale, which consists of 14 items ranging from 0 - 56 (higher equals more anxiety).
Time frame: one year
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Enrollment
315
Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale
The depression in bronchiectasis patients will be measured using the Hamilton Depression rating scale, which consists of 17 items ranging from 0 - 52 (higher equals more depression).
Time frame: one year