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NCT04630301 · ClinicalTrials.gov registry record
Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 37
- Enrollment target
NCT04630301: Completed study, sponsored by Johns Hopkins University.
NCT04630301 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630301 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 37 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-02-17 |
| Est. Completion | 2025-07-31 |
What the finished NCT04630301 record still lists
NCT04630301 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 37 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04630301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04630301 about?
NCT04630301 is a clinical study titled "Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax". 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...
What is the current status of trial NCT04630301?
This trial is currently completed. The enrollment target is 37 participants. The study started on 2021-02-17. Estimated completion is 2025-07-31.
Who is sponsoring clinical trial NCT04630301?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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