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Interventional Treatment of Refractory Pneumothorax by Bronchoscope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352012
Recruitment Status : Unknown
Verified January 2016 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : January 30, 2015
Last Update Posted : January 6, 2016
Sponsor:
Collaborators:
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.
Information provided by (Responsible Party):
Tang-Du Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumothorax Other: Autologous blood Device: Bronchial plug Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-site Randomized Controlled Study of Interventional Treatment of Refractory Pneumothorax by Bronchoscope
Study Start Date : February 2015
Actual Primary Completion Date : February 2015
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

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



Primary Outcome Measures :
  1. Duration of air leakage [ Time Frame: up to two weeks ]

Secondary Outcome Measures :
  1. duration of pulmonary atelectasis [ Time Frame: up to two weeks ]

Other Outcome Measures:
  1. Arterial blood gas [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  2. 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 )

  3. hospital costs [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  4. Duration of hospital stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352012


Contacts
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Contact: Wangping Li, MD 8618066620066; 8629-778526 qxd25@163.com
Contact: Yun Li, MD 8618629675387 littleyun@126.com

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi`an, Shaanxi, China, 710038
Contact: Wangping Li, MD    8618066620066; 862984778526    qxd25@163.com   
Contact: Yun Li, MD    8618629675387    littleyun@126.com   
Principal Investigator: Wangping Li, MD         
Sponsors and Collaborators
Tang-Du Hospital
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.
Investigators
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Principal Investigator: Faguang Jin, MD & PhD Tang-Du Hospital
Additional Information:
Publications:

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02352012    
Other Study ID Numbers: tdhx007
201402024007 ( Other Grant/Funding Number: 201402024 )
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Keywords provided by Tang-Du Hospital:
Interventional Treatment
Refractory Pneumothorax
Bronchoscope
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases