Pneumothorax
Conditions
Keywords
Interventional Treatment, Refractory Pneumothorax, Bronchoscope
Brief summary
The purpose of this study is to determine whether injecting autologous blood or putting bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.
Detailed description
This is a multi-site, controlled, randomized study. Refractory pneumothorax is a challenge for respiratory physicians. Many patients present recurrent pneumothorax. Thoracic closed drainage is a basic and effective treatment to pneumothorax. Chronic obstructive pulmonary disease(COPD)is one of the main causes of spontaneous pneumothorax. Many patients precluded the performance of surgery for poor pulmonary function. In China, economical load is another reason for patients who are unwilling to surgery. So we want to seek a cheap, effective and safe method for refractory pneumothorax. We will adopt three methods in this study. Conventional thoracic closed drainage was continuously used in the control group, autologous blood was perfused to the target pulmonary segment in the treatment A group and self-made silicone bronchial plug was placed to the target pulmonary segment in the treatment B group. The leak position was detected by biliary lithotomy balloon. Main outcome measures: duration of continuous leakage. Secondary end-points included the lung reexpanded, hospital costs and hospital stays etc.
Interventions
OTHERAutologous blood
Autologous blood was perfused to the target pulmonary segment
DEVICEBronchial plug
Bronchial plug was placed to the target pulmonary segment
Sponsors
Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Third Military Medical University
China Meitan General Hospital
Micro-Tech (Nanjing) Co., Ltd.
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Spontaneous pneumothorax has been treating with thoracic closed drainage for 7 days, the patient has still persistent air leakage; * Patients informed consent to participate in this study and can complete the requirements of the follow-up visit
Exclusion criteria
* Patients with severe abnormal gas exchange are defined as PaCO2\>50mmHg(6.6kPa) or PaO2\<45mmHg(6.0kPa) ; * Patients have systemic disease or cancer which affect the survival time ; * Patients have other serious diseases (the researchers think patient is not an appropriate candidate) which affect the evaluation or follow-up in research; * Patients are not suitable for or unable to tolerate bronchoscopy procedures; * Patients have active tuberculosis; * Patients have any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints including interference test of nerves or skeletal muscle disease; * Patients have demonstrated unwillingness or inability to complete screening or baseline data collection procedures; * Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study; * Female patient of childbearing potential has a positive result from a pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of air leakage | up to two weeks |
Secondary
| Measure | Time frame |
|---|---|
| duration of pulmonary atelectasis | up to two weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| hospital costs | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | — |
| Duration of hospital stays | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | — |
| Arterial blood gas | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | — |
| complications | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Complications refers to the complications related to bronchoscopy treatment(include hemoptysis, short of breath, chest pain, fever ) |
Countries
China
Contacts
Primary ContactWangping Li, MD
Backup ContactYun Li, MD
Outcome results
None listed