Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax
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|ClinicalTrials.gov Identifier: NCT04630301|
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : February 18, 2021
|Condition or disease|
|Pneumothorax Tension Pneumothorax|
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|Official Title:||Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax|
|Actual Study Start Date :||February 17, 2021|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||December 20, 2021|
Measurement of pleural pressure
a. Patients admitted to the Johns Hopkins Hospital with spontaneous, iatrogenic, or tension pneumothorax referred to the Division of Interventional Pulmonology for thoracostomy will be recruited. Using standard sterile technique, a 14fr catheter will be inserted into the pleural space. An electronic manometer (Compass, Medline Industries, Inc.) will be connected in-line to the introducer needle and Ppl will be recorded for 3-5 respiratory cycles. After measurement, the manometer will be removed and the catheter will remain in place per routine standards of practice.
- Pleural pressure (Ppl) prior to evacuation of pleural air [ Time Frame: Upon needle insertion into the pleural space and for 5 breath cycles, up to 60 seconds ]Ppl is reported in centimeters of water (cmH2O)
- Duration (days) of chest tube placement [ Time Frame: Up to 30 days ]Number of days that chest tube is in place.
- Referral for pleurodesis [ Time Frame: Up to 30 days ]Was the patient referred for pleurodesis (yes/no).
- Intrabronchial valve (IBV) placement [ Time Frame: Up to 30 days ]Was the patient treated with an intrabronchial valve (yes/no).
- Referral for video assisted thoracoscopic surgery (VATS) [ Time Frame: Up to 30 days ]Was the patient referred for video assisted thoracoscopic surgery (yes/no).
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): NCT04630301
|Contact: David Feller-Kopman, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: David Feller-Kopman 410-502-7046 email@example.com|
|Principal Investigator:||David Feller-Kopman, MD||Johns Hopkins University|