NCT02677883

Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial attempts to determine whether the measurement of pleural pressures during therapeutic thoracentesis affects the development of chest discomfort after the procedure. During thoracentesis, pleural fluid is drained from the pleural space, resulting in lung expansion. In some cases, the lung is not completely re-expandable, in which case continued drainage results in the development of negative pleural pressures and chest discomfort. Negative pleural pressures may also result in other complications such as re-expansion pulmonary edema and pneumothorax. The identification of negative pleural pressures via manometry during the procedure may lead to a reduction in the complication rate.

Detailed description

PRIMARY OBJECTIVES: I. To study the impact of pleural manometry on the development of chest discomfort during therapeutic thoracentesis compared to conventional symptom-guided thoracentesis. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo manometry-guided therapeutic thoracentesis. ARM II: Patients undergo symptom-guided thoracentesis.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
OTHER	Manometry-guided thoracentesis	Arm I will undergo a standard of care therapeutic thoracentesis procedure, and in addition include pleural pressure monitoring (via an FDA-approved digital manometer) which is also standard of care but left at the discretion of physicians as per expert recommendations. In this group, the procedure will be stopped when the patient develops symptoms or when all the fluid has been removed, and will also be stopped if the pressure begins to fall quickly in the fluid collection.
OTHER	Symptom-guided thoracentesis	Arm II will undergo a standard of care therapeutic thoracentesis procedure. In this group, the procedure but will be stopped when the patient develops symptoms or when all the fluid has been removed.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-10-26
• Completion: 2019-03-08
• First posted: 2016-02-09
• Last updated: 2019-09-26

Locations

1 site across 1 country: United States