Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax

NCT04630301 | Completed Results

• 1 other identifier: IRB00256185
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 4

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.

Conditions

Pneumothorax; Tension Pneumothorax

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Duration (Days) of Chest Tube Placement

  Up to 30 days

• Referral for Pleurodesis

  Up to 30 days

• Intrabronchial Valve (IBV) Placement

  Up to 30 days

• Referral for Video Assisted Thoracoscopic Surgery (VATS)

  Up to 30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• bilateral pneumothorax

Sponsors & Collaborators

• Johns Hopkins University: lead
• Medline Industries, Inc: collaborator

Study Sites (4)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (12)

• Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. doi: 10.1056/NEJM200003233421207. No abstract available.

  PMID: 10727592 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.

  PMID: 20696690 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.

  PMID: 25918121 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.

  PMID: 31995686 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.

  PMID: 15596671 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.

  PMID: 17954079 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.

  PMID: 7406313 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.

  PMID: 9148649 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.

  PMID: 24853674 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.

  PMID: 11147314 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.

  PMID: 31888739 BACKGROUND

• 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. 2025 Oct 10:S0012-3692(25)05492-3. doi: 10.1016/j.chest.2025.09.121. Online ahead of print.

  PMID: 41076067 DERIVED

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Jeffrey Thiboutot
• Organization: Johns Hopkins University

jthibou1@jhmi.edu

410-502-2533

Study Officials

• Jeffrey Thiboutot, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: February 17, 2021
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: October 20, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)