Interventional Treatment of Refractory Pneumothorax by Bronchoscope

January 4, 2016 updated by: Tang-Du Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

269

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:
        • Contact:
          • Wangping Li, MD
          • Phone Number: 8618066620066; 862984778526
          • Email: qxd25@163.com
        • Principal Investigator:
          • Wangping Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous blood group A
Autologous blood was perfused to the target pulmonary segment
Other: Autologous blood
Autologous blood was perfused to the target pulmonary segment
Experimental: Bronchial plug group B
Bronchial plug was placed to the target pulmonary segment
Device: Bronchial plug
Bronchial plug was placed to the target pulmonary segment
No Intervention: control group
Control group was given to continuous negative pressure drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of air leakage
Time Frame: up to two weeks
up to two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of pulmonary atelectasis
Time Frame: up to two weeks
up to two weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gas
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
complications
Time Frame: 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 )
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
hospital costs
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Duration of hospital stays
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Collaborators

Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
China Meitan General Hospital
Second Affiliated Hospital of Third Military Medical University
Micro-Tech (Nanjing) Co., Ltd.

Investigators

  • Principal Investigator: Faguang Jin, MD & PhD, Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2015

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tdhx007
  • 201402024007 (Other Grant/Funding Number: 201402024)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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