Clinical trial NCT02352012: Interventional Treatment of Refractory Pneumothorax by Bronchoscope
Official title: A Multi-site Randomized Controlled Study of Interventional Treatment of Refractory Pneumothorax by Bronchoscope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumothorax
Keywords: Interventional Treatment
Refractory Pneumothorax
Bronchoscope
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Second Affiliated Hospital of Third Military Medical University
name: China Meitan General Hospital
name: Micro-Tech (Nanjing) Co., Ltd.
First posted: 2015-01-30
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of air leakage
timeFrame: up to two weeks
Secondary outcomes:
measure: duration of pulmonary atelectasis
timeFrame: up to two weeks
Other outcomes:
measure: Arterial blood gas
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: complications
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: hospital costs
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Duration of hospital stays
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Faguang Jin, MD & PhD
role: PRINCIPAL_INVESTIGATOR
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