NCT02352012

Interventional Treatment of Refractory Pneumothorax by Bronchoscope

A Multi-site Randomized Controlled Study of Interventional Treatment of Refractory Pneumothorax by Bronchoscope

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 269 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumothorax

Interventions

Type	Name	Description
OTHER	Autologous blood	Autologous blood was perfused to the target pulmonary segment
DEVICE	Bronchial plug	Bronchial plug was placed to the target pulmonary segment

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-02-01
• Completion: 2017-06-01
• First posted: 2015-01-30
• Last updated: 2016-01-06

Locations

1 site across 1 country: China