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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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Intrapleural pressures have been shown to be a useful clinical predictor in pleural effusions, however it's utility has not been described in pneumothorax. Data on intrapleural pressures in pneumothorax are limited. Furthermore, the pleural pressure in tension pneumothorax is theorized to be greater than atmospheric pressure, though this has never been verified. Pneumothorax is primarily treated with a tube thoracostomy. This observational study will record intrapleural pressures in participants with pneumothorax undergoing a tube thoracostomy. Clinical outcomes of participants will then be monitored for need for pleurodesis, intrabronchial valve placement, and video assisted thoracoscopic surgery (VATS) to identify a correlation with intrapleural pressure.

Condition or disease
Pneumothorax Tension Pneumothorax

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Group/Cohort
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Duration (days) of chest tube placement [ Time Frame: Up to 30 days ]
    Number of days that chest tube is in place.

  2. Referral for pleurodesis [ Time Frame: Up to 30 days ]
    Was the patient referred for pleurodesis (yes/no).

  3. Intrabronchial valve (IBV) placement [ Time Frame: Up to 30 days ]
    Was the patient treated with an intrabronchial valve (yes/no).

  4. Referral for video assisted thoracoscopic surgery (VATS) [ Time Frame: Up to 30 days ]
    Was the patient referred for video assisted thoracoscopic surgery (yes/no).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 or older admitted to the Johns Hopkins Hospital with clinical or radiographic evidence of new pneumothorax who are referred to Interventional Pulmonology for needle aspiration or tube thoracostomy.
Criteria

Inclusion Criteria:

  • patients aged 18 or older admitted to the Johns Hopkins Hospital with clinical or radiographic evidence of new pneumothorax who are referred to Interventional Pulmonology for needle aspiration or tube thoracostomy. TP will be defined as a pneumothorax that results in mean arterial pressure <65 or systolic BP < 90.

Exclusion Criteria:

  • bilateral pneumothorax

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): NCT04630301


Contacts
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Contact: David Feller-Kopman, MD 4105027046 dfk@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: David Feller-Kopman    410-502-7046    dfk@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: David Feller-Kopman, MD Johns Hopkins University
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04630301    
Other Study ID Numbers: IRB00256185
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases