Postoperative lung infection
Conditions
Interventions
Experimental Group:Intraoperative topical nebulized amikacin administration during BTVA and perioperative prophylactic antibiotic therapy
Control Group:Undergo BTVA and perioperative prophylactic antibiotic therapy
Sponsors
Shenzhen Guangming District People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following to be eligible for inclusion in this study: 1) Male or female, =40 and =75 years of age; 2) FEV1% predicted must be between 20% and 45%; 3) Residual Volume (RV) > 150% of predicted value; 4) 6-min walk test >140 meters; 5) Patients with severe emphysema to be treated by BTVA; 6) Have fully understood the content of the trial and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects were not eligible for enrollment if they met any of the following conditions: 1) Respiratory infection or exacerbation of COPD within the last 6 weeks; 2) Active bacterial infection or symptoms of active infection (i.e., fever, elevated white blood cell count); 3) Contraindications to aminoglycoside antibiotics; 4) More than 3 hospitalizations due to COPD exacerbations in the past 12 months; 5) More than 3 instances of lower respiratory tract infections requiring antibiotics in the past 12 months; 6) Poorly controlled gastroesophageal reflux disease, defined as significant treatment escalation in the past 6 weeks; 7) Contraindications to undergoing bronchoscopy; 8) Other conditions deemed by the investigators as unsuitable for participation in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group differences in the incidence of new or progressive pulmonary infections within 28 days postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group differences in the proportion of patients receiving upgraded antibiotic treatment within 28 days after surgery;Between-group differences in length of hospital stay at 28 days after surgery;Between-group differences in sputum score changes from baseline at 28 days;Between-group differences in bacterial distribution and multidrug-resistant characteristics in sputum culture at 28 days after surgery;Number of times emergency medication is used;Between-group differences in improvement of lung function from baseline at 28 days after surgery; | — |
Countries
China
Contacts
Public ContactLong Fa
Shenzhen Guangming District People's Hospital
Outcome results
None listed