N/A
N=100
Vacuum vs Manual Drainage During Unilateral Thoracentesis
Pleural Effusion · Pleural Diseases · Thoracic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03496987 ↗Enrolled (actual)
100
Serious AEs
5.0%
Results posted
Aug 2018
Primary outcome: Primary: Pain Change — 0.53; 1.43 Pre-post NPRS Pain Scale Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vacuum Bottle Drainage (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Change |
0.53; 1.43 | — |
| SECONDARY Time of Drainage |
498.5; 318.6 | — |
| SECONDARY Number of Patients Who Had an Early Termination of Procedure |
1; 8 | — |
| SECONDARY Number of Patients Who Had a Complication as a Result of the Procedure |
0; 3; 0; 1; 0; 1 | — |
| SECONDARY Etiology of Effusion |
13; 8; 7; 2; 7; 8 | — |
| SECONDARY Volume of Effusion |
1023; 1143 | — |
| SECONDARY Laterality of Effusion |
17; 23; 32; 28 | — |
Summary
The purpose of this study is to determine if there are any differences in terms of safety, pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing unilateral therapeutic thoracentesis
Exclusion Criteria
- Patients with a history of prior significant pleural or lung based procedures/surgeries (not a simple thoracentesis)
- Prior enrollment in this study
- Patients ability to comprehend and consent to this procedure and clearly communicate any pain or other symptoms that arise from this procedure
Data sourced from ClinicalTrials.gov (NCT03496987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.