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| Name | Class |
|---|---|
| Medline Industries | INDUSTRY |
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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.
The rate of hospitalization for spontaneous pneumothorax among people age 14 or older is approximately 227 per million. Spontaneous pneumothorax in the absence of trauma can be further classified as primary spontaneous pneumothorax (PSP) or secondary spontaneous pneumothorax (SSP) based on the absence or presence of underlying structural lung disease, respectively. Though recent studies suggest that in some cases conservative management with close observation is an acceptable treatment, definitive evacuation remains a cornerstone of management for patients who are symptomatic or who have a large pneumothorax. Intrapleural air can be removed by either needle aspiration or introduction of a watersealed catheter into the pleural space. In the event of tension pneumothorax (TP), emergent chest thoracostomy is preferred. In all cases, the goal of treatment remains to re-expand the affected lung, after which the catheter may be removed. If the visceral pleural defect is not healed after 5 days, it is deemed a persistent air leak. In these cases, the chest tube is maintained and more aggressive measures such as pleurodesis, placement of an intrabronchial valve (IBV), or VATS are performed. Unfortunately, there is currently no method to predict which patients will require these more invasive procedures.
The lack of prognostic indicators is not the case in pleural effusions, however. Pleural manometry has been shown to be a useful tool in the management of patients with effusions. Doelken et al. described using an overdamped water manometer or an electronic transducer connected to a thoracentesis catheter for the direct measurement of Ppl with similar accuracy. Traditionally, thoracenteses are aborted after onset of dyspnea or cough, all fluid is drained, or 1 liter of fluid has been removed. This 1 liter limit exists to avoid the feared complicated of reexpansion pulmonary edema. However, monitoring of Ppl during drainage and aborting the procedure once Ppl drops below -20 cmH2O allows for safe drainage of often larger volumes. - Furthermore, it has been demonstrated that Ppl could diagnose non-expandable lung and predict pleurodesis failure in patients with malignant effusion. We recently reported the use of a simple, in-line, digital manometer to measure Ppl in patients with pleural effusion.
Routine use of pleural manometry in the evaluation and management of pneumothorax has not yet been adopted, likely due to the historical difficulty in obtaining measurements and the uncertain clinical benefit pleural manometry provided. It has been found that Ppl in spontaneous pneumothorax was greater in patients that required prolonged drainage. These results were later supported in a study that demonstrated the practicality of measuring Ppl in pneumothorax. Ppl measurements required only up to 30 seconds by using an electronic manometer connected to an intrapleural catheter. Still to date, Ppl in TP have yet to be reported. Ultimately, measurement of Ppl in pneumothorax may help identify patients at increased risk for the need of advanced therapies such as IBV placement, pleurodesis, or VATS. Early identification of these high-risk patients will allow for these interventions to be performed earlier, thus reducing hospital length of stay, associated complications, and health-care costs.
4. Study Procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pleural Pressure (Ppl) Prior to Evacuation of Pleural Air | Ppl is reported in centimeters of water (cmH2O). The normal pleural pressure (Ppl), the pressure within the space between the lung and chest wall, is typically subatmospheric, ranging from -3 to -5 cmH2O. This negative pressure is crucial for keeping the lungs inflated and facilitating normal breathing. In this study, all subjects have pneumothorax so will have abnormal Ppl greater than -3. Tension pneumothorax will have a positive Ppl. There is no known 'normal' or 'expected' value. | Upon needle insertion into the pleural space and for 5 breath cycles, up to 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Duration (Days) of Chest Tube Placement | Number of days that chest tube is in place. | Up to 30 days |
| Referral for Pleurodesis | Was the patient referred for pleurodesis (yes/no). Outcome value is for "yes" responses. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Thiboutot, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| University of Michigan Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10727592 | Background | Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. doi: 10.1056/NEJM200003233421207. No abstract available. | |
| 20696690 | Background | MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pleural Pressure (Ppl) Prior to Evacuation of Pleural Air | Ppl is reported in centimeters of water (cmH2O). The normal pleural pressure (Ppl), the pressure within the space between the lung and chest wall, is typically subatmospheric, ranging from -3 to -5 cmH2O. This negative pressure is crucial for keeping the lungs inflated and facilitating normal breathing. In this study, all subjects have pneumothorax so will have abnormal Ppl greater than -3. Tension pneumothorax will have a positive Ppl. There is no known 'normal' or 'expected' value. | Posted | Mean | Standard Deviation | cmH2O | Upon needle insertion into the pleural space and for 5 breath cycles, up to 60 seconds |
|
Up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Thiboutot | Johns Hopkins University | 410-502-2533 | jthibou1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2021 | Jul 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2021 | Jul 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| Up to 30 days |
| Intrabronchial Valve (IBV) Placement | Was the patient treated with an intrabronchial valve (yes/no). Outcome value is for "yes" responses. | Up to 30 days |
| Referral for Video Assisted Thoracoscopic Surgery (VATS) | Was the patient referred for video assisted thoracoscopic surgery (yes/no). Outcome value is for "yes" responses. | Up to 30 days |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| 25918121 | Background | Bobbio A, Dechartres A, Bouam S, Damotte D, Rabbat A, Regnard JF, Roche N, Alifano M. Epidemiology of spontaneous pneumothorax: gender-related differences. Thorax. 2015 Jul;70(7):653-8. doi: 10.1136/thoraxjnl-2014-206577. Epub 2015 Apr 27. |
| 31995686 | Background | Brown SGA, Ball EL, Perrin K, Asha SE, Braithwaite I, Egerton-Warburton D, Jones PG, Keijzers G, Kinnear FB, Kwan BCH, Lam KV, Lee YCG, Nowitz M, Read CA, Simpson G, Smith JA, Summers QA, Weatherall M, Beasley R; PSP Investigators. Conservative versus Interventional Treatment for Spontaneous Pneumothorax. N Engl J Med. 2020 Jan 30;382(5):405-415. doi: 10.1056/NEJMoa1910775. |
| 15596671 | Background | Doelken P, Huggins JT, Pastis NJ, Sahn SA. Pleural manometry: technique and clinical implications. Chest. 2004 Dec;126(6):1764-9. doi: 10.1378/chest.126.6.1764. |
| 17954079 | Background | Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg. 2007 Nov;84(5):1656-61. doi: 10.1016/j.athoracsur.2007.06.038. |
| 7406313 | Background | Light RW, Jenkinson SG, Minh VD, George RB. Observations on pleural fluid pressures as fluid is withdrawn during thoracentesis. Am Rev Respir Dis. 1980 May;121(5):799-804. doi: 10.1164/arrd.1980.121.5.799. |
| 9148649 | Background | Lan RS, Lo SK, Chuang ML, Yang CT, Tsao TC, Lee CH. Elastance of the pleural space: a predictor for the outcome of pleurodesis in patients with malignant pleural effusion. Ann Intern Med. 1997 May 15;126(10):768-74. doi: 10.7326/0003-4819-126-10-199705150-00003. |
| 24853674 | Background | Lee HJ, Yarmus L, Kidd D, Amador RO, Akulian J, Gilbert C, Hughes A, Thompson RE, Arias S, Feller-Kopman D. Comparison of pleural pressure measuring instruments. Chest. 2014 Oct;146(4):1007-1012. doi: 10.1378/chest.13-3004. |
| 11147314 | Background | Herrejon A, Inchaurraga I, Vivas C, Custardoy J, Marin J. Initial pleural pressure measurement in spontaneous pneumothorax. Lung. 2000;178(5):309-16. doi: 10.1007/s004080000034. |
| 31888739 | Background | Kaneda H, Nakano T, Murakawa T. Measurement of intrapleural pressure in patients with spontaneous pneumothorax: a pilot study. BMC Pulm Med. 2019 Dec 30;19(1):267. doi: 10.1186/s12890-019-1038-9. |
| 41076067 | Derived | Latifi A, Wang D, Backer ED, Madisi N, Chopra A, Kapp CM, Wayne M, Howe J, Pai C, Yarmus L, Feller-Kopman D, Thiboutot J. Pleural Manometry in Pneumothorax: Evaluating Tension Physiology and Predicting Outcomes. Chest. 2026 Mar;169(3):830-836. doi: 10.1016/j.chest.2025.09.121. Epub 2025 Oct 10. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Non-Tension group of pneumothorax subjects |
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| Secondary | Duration (Days) of Chest Tube Placement | Number of days that chest tube is in place. | Participants with data collected | Posted | Mean | Full Range | days | Up to 30 days |
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|
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| Secondary | Referral for Pleurodesis | Was the patient referred for pleurodesis (yes/no). Outcome value is for "yes" responses. | Posted | Count of Participants | Participants | Up to 30 days |
|
|
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| Secondary | Intrabronchial Valve (IBV) Placement | Was the patient treated with an intrabronchial valve (yes/no). Outcome value is for "yes" responses. | Posted | Count of Participants | Participants | Up to 30 days |
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|
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| Secondary | Referral for Video Assisted Thoracoscopic Surgery (VATS) | Was the patient referred for video assisted thoracoscopic surgery (yes/no). Outcome value is for "yes" responses. | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| 6 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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