Interventional Treatment of Refractory Pneumothorax by Bronchoscope

Tang-Du Hospital

Status: Unknown

Conditions: Pneumothorax

Treatments: Device: Bronchial plug; Other: Autologous blood

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02352012

201402024007 (Other Grant/Funding Number)

tdhx007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 269 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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269 participants in 3 patient groups

Autologous blood group A

Experimental group

Description:

Autologous blood was perfused to the target pulmonary segment

Treatment:

Other: Autologous blood

Bronchial plug group B

Experimental group

Description:

Bronchial plug was placed to the target pulmonary segment

Treatment:

Device: Bronchial plug

control group

No Intervention group

Description:

Control group was given to continuous negative pressure drainage