NCT04630301

Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax

Completed Results posted Last updated 20 October 2025

What this trial tests

trial in Pneumothorax in 37 participants. Completed in 31 July 2025.

Timeline

17 February 2021

Primary endpoint
30 June 2025

31 July 2025

Quick facts

Lead sponsor	Johns Hopkins University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	37
Start date	17 February 2021
Primary completion	30 June 2025
Estimated completion	31 July 2025
Sites	4 locations across United States

Conditions studied

• Pneumothorax — all drugs for Pneumothorax →
• Tension Pneumothorax — all drugs for Tension Pneumothorax →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Pneumothorax or Tension Pneumothorax. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pleural Pressure (Ppl) Prior to Evacuation of Pleural Air Primary · Upon needle insertion into the pleural space and for 5 breath cycles, up to 60 seconds

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.

Group	Value	95% CI
Tension Participants	7.44	± 6.37
Non-tension Participants	-1.79	± 4.49

Duration (Days) of Chest Tube Placement Secondary · Up to 30 days

Number of days that chest tube is in place.

Group	Value	95% CI
Measurement of Pleural Pressure	4.30303	0 – 27

Referral for Pleurodesis Secondary · Up to 30 days

Was the patient referred for pleurodesis (yes/no). Outcome value is for "yes" responses.

Group	Value	95% CI
Tension Participants	1
Non-tension Participants	4

Intrabronchial Valve (IBV) Placement Secondary · Up to 30 days

Was the patient treated with an intrabronchial valve (yes/no). Outcome value is for "yes" responses.

Group	Value	95% CI
Measurement of Pleural Pressure	3

Referral for Video Assisted Thoracoscopic Surgery (VATS) Secondary · Up to 30 days

Was the patient referred for video assisted thoracoscopic surgery (yes/no). Outcome value is for "yes" responses.

Group	Value	95% CI
Measurement of Pleural Pressure	1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pleural Manometry in Pneumothorax: Evaluating Tension Physiology and Predicting Outcomes.
   Latifi A, Wang D, Backer ED, Madisi N, et al · · 2026 · PMID 41076067 · DOI 10.1016/j.chest.2025.09.121