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NCT02677883 · ClinicalTrials.gov registry record · NA
Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis
A NA study of Pleural Effusion, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 89
- Enrollment target
- 1
- Study location
NCT02677883: Completed NA study of Pleural Effusion, sponsored by Vanderbilt-Ingram Cancer Center.
NCT02677883 is a NA study of Pleural Effusion that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 89 participants, below the 182-participant average among 6 other Pleural Effusion trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02677883, a NA study of Pleural Effusion, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 89 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
As measured in millimeters along a 10 cm Visual Analog Scale (VAS). The estimated minimal clinically important difference is 15 mm. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention versus (vs) control, will be made u
Conditions Studied
Interventions
- OTHER Manometry-guided thoracentesis
- OTHER Symptom-guided thoracentesis
Study Locations (1)
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-03-08 |
| Phase | NA |
What the finished NCT02677883 record still lists
NCT02677883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 182-participant average among 6 other Pleural Effusion trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Pleural Effusion appearing as the primary indexed condition, and to 2 interventions - of which Manometry-guided thoracentesis is the first listed.
NCT02677883 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02677883 about?
NCT02677883 is a clinical study titled "Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis". 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...
What is the current status of trial NCT02677883?
This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2016-01. Estimated completion is 2019-03-08.
What conditions does trial NCT02677883 study?
This clinical trial studies the following conditions: Pleural Effusion.
What interventions are being tested in trial NCT02677883?
The interventions under investigation include: Manometry-guided thoracentesis (OTHER), Symptom-guided thoracentesis (OTHER).
Who is sponsoring clinical trial NCT02677883?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02677883 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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