Bronchiectasis with Acute Exacerbation
Conditions
Keywords
bronchiectasis; acetylcysteine; bronchoalveolar lavage; Bronchoscopic airway clearance therapy
Brief summary
Bronchiectasis is a clinical syndrome characterised by chronic cough, profuse sputum and/or intermittent haemoptysis, with or without shortness of breath and respiratory failure of varying severity, and abnormal thickening and dilatation of the bronchial walls as seen on lung imaging. Nebulised inhalation of N-acetylcysteine has been shown to significantly improve symptoms, shorten the length of hospital stay, reduce the rate of re-hospitalisation within six months, and improve lung function in patients with bronchiectasis with a high degree of safety. There have been no studies on the efficacy and safety of bronchoscopic irrigation with N-acetylcysteine solution in the treatment of bronchiectasis. The aim of this study was to investigate whether bronchoscopic acetylcysteine lavage combined with conventional treatment is more beneficial to patients with bronchiectasis than conventional treatment combined with conventional bronchoalveolar lavage and conventional treatment without bronchoscopy, respectively.
Detailed description
All patients enrolled were patients with acute exacerbation of bronchiectasis. A total of 180 patients (1:1:1 allocation) with acute exacerbation of bronchiectasis were to be enrolled. The patients were divided into control group A (conventional clinical treatment including anti-infective and expectorant therapy), control group B (bronchoalveolar lavage with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml), and experimental group C (bronchoalveolar lavage with acetylcysteine solution in combination with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml).
Interventions
PROCEDUREBronchoalveolar Lavage
Bronchoalveolar lavage with saline or saline-acetylcysteine solution on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml.
Sponsors
Shenzhen Third People's Hospital
Anhui Chest Hospital
Ninghai First Hospital
Jingzhou Central Hospital
First Affiliated Hospital of Ningbo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects were blinded. Study personnel responsible for assessing patients' symptom scores and recording information on acute exacerbations were blinded whenever possible. The bronchoscopy operator responsible for giving bronchoalveolar lavage treatment and the person in charge of the patient's bed were not blinded. To avoid subjective bias on the part of the assessor, non-blind people should not disclose blinded information to the assessor.
Intervention model description
Control group A (conventional clinical treatment), Control group B (application of saline bronchoalveolar lavage based on conventional clinical treatment), and group C (application of bronchoscopic acetylcysteine combined with saline alveolar lavage based on conventional clinical treatment), were randomly selected into the groups according to a predefined sequence of randomisation tables prior to the operation due to the nature of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤80 years; 2. Chest CT suggestive of bronchiectasis; 3. meet the criteria for an acute exacerbation of bronchiectasis with symptoms such as cough, sputum, chest tightness or wheezing, and c. Patients who meet the criteria for an acute exacerbation of bronchiectasis with symptoms of cough, sputum, chest tightness or wheezing and who consent to bronchoscopy with bronchoalveolar lavage 4. patients who agreed to participate in the study and signed an informed consent form;
Exclusion criteria
1. Severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, psychiatric disorders or severe neuroses that are contraindications to bronchoscopy; 2. Intraoperative findings of decreased SPO2 or inability to tolerate bronchoscopy or inability to tolerate further bronchoalveolar lavage; 3. Inability to co-operate with the study for any reason or in the opinion of the investigator, inappropriate for inclusion in the study for other reasons; 4. Bronchoscopy of patients with significant intra-airway haemorrhage who may be at risk of exacerbation due to bronchoalveolar lavage; 5. Patients with acetylcysteine allergy; 6. Missing information;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of first and second acute exacerbation | six months | Description: Length of post-treatment time points to first acute exacerbation (days) and length of time points to second acute exacerbation (days) in all three groups of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of CAT scores. | one month | COPD assessment test (CAT) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). A score of 0-10 is considered mild, 11-20 is considered moderate, 21-30 is considered severe, and 31-40 is considered very severe. |
| The change of LCQ scores. | one month | Leicester Cough Questionnaire (LCQ) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). Scores range from 3 to 21, with lower scores suggesting that cough has a greater impact on quality of life. |
| The change of SGQR scores. | one month | St George's Respiratory Questionnaire (SGRQ) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). The total score ranges from 0 to 100. Higher scores indicate poorer quality of life for the patient. |
| The change of mMRC scores | one month | The modified Medical Research Council (mMRC) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). Categorised on a scale of 0 to 4, the higher the scale the more severe the symptoms are. |
| adverse effects | one month | Occurrence of post-treatment adverse effects (chest tightness, shortness of breath, worsening of respiratory failure, worsening of haemoptysis, complication of new pneumonia foci or signs of significant new infections considered to be related to lavage treatment) in the three groups of patients. |
| Re-treatment with bronchoalveolar lavage | six months | Hospitalisation for acute exacerbations requiring re-bronchoscopic lavage within 6 months in all three groups (re-bronchoscopic lavage may be considered for exacerbations after treatment: significant increase in sputum output, increase in the size of the lesion on CT). |
| Number of acute exacerbations | six months | Number of acute exacerbations in the three groups at 6 months after treatment. |
Countries
China
Contacts
Primary ContactZhongbo Chen
Outcome results
None listed