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Vacuum vs Manual Drainage During Unilateral Thoracentesis

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ClinicalTrials.gov Identifier: NCT03496987
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : August 31, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pleural Effusion
Pleural Diseases
Thoracic Diseases
Intervention Device: Vacuum Bottle Drainage
Enrollment 100
Recruitment Details Inpatients, who were awake, consentable, and undergoing unilateral thoracentesis
Pre-assignment Details  
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Period Title: Overall Study
Started 49 51
Completed 49 51
Not Completed 0 0
Arm/Group Title Manual Drainage Vacuum Bottle Drainage Total
Hide Arm/Group Description Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Total of all reporting groups
Overall Number of Baseline Participants 49 51 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 100 participants
68.5  (16.2) 65.6  (15.5) 67  (15.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
Female
26
  53.1%
22
  43.1%
48
  48.0%
Male
23
  46.9%
29
  56.9%
52
  52.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 51 participants 100 participants
49 51 100
1.Primary Outcome
Title Pain Change
Hide Description

Difference in pain between pre-procedural pain and during drainage pain as measured as the difference between a pre-procedural NPSS pain score (range from 0 (no pain) to 10 (maximum pain)). This was asked again during drainage and the difference between the two was recorded. The values ranged from -10 to 10 (with a more negative number representing a decrease in pain and a more positive number representing an increase in pain)

The scale used is called The Numeric Pain Rating Scale. With ratings from 0-10. Zero is the least amount of pain experienced while 10 is the worst pain possible.

Time Frame 5-20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: Pre-post NPRS Pain Scale Score
0.53  (1.7) 1.43  (2.7)
2.Secondary Outcome
Title Time of Drainage
Hide Description Actual time of drainage in seconds for each patient.
Time Frame 5-20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: seconds
498.5  (386.5) 318.6  (193)
3.Secondary Outcome
Title Number of Patients Who Had an Early Termination of Procedure
Hide Description Patients who had procedure termination prior to complete evacuation of the pleural contents (usually as a result of refractory pain or another symptom that the patient perceived).
Time Frame 5-20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 51
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
8
  15.7%
4.Secondary Outcome
Title Number of Patients Who Had a Complication as a Result of the Procedure
Hide Description Any complications that occur as a direct result of the procedure. We tracked patients for 7 days after the procedure to capture any complications (which is typical clinical practice)
Time Frame <7 days
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 50
Measure Type: Count of Participants
Unit of Measure: Participants
Pneumothorax
0
   0.0%
3
   6.0%
Hemothorax
0
   0.0%
1
   2.0%
Clinically Significant Pulmonary Edema
0
   0.0%
1
   2.0%
5.Secondary Outcome
Title Etiology of Effusion
Hide Description Clinical etiology of effusion
Time Frame <7 days
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 50
Measure Type: Count of Participants
Unit of Measure: Participants
Malignant
13
  26.5%
8
  16.0%
Paramalignant
7
  14.3%
2
   4.0%
Heart Failure
7
  14.3%
8
  16.0%
Hepatic Hydrothorax
3
   6.1%
5
  10.0%
Post-Cardiothoracic Procedure
13
  26.5%
17
  34.0%
Parapneumonic
3
   6.1%
2
   4.0%
Unknown
3
   6.1%
8
  16.0%
6.Secondary Outcome
Title Volume of Effusion
Hide Description Volume of effusion drained (in mL)
Time Frame <20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: milliters
1023  (674) 1143  (775)
7.Secondary Outcome
Title Laterality of Effusion
Hide Description Laterality of effusion (left or right)
Time Frame <20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description:
Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

Overall Number of Participants Analyzed 49 51
Measure Type: Count of Participants
Unit of Measure: Participants
Left
17
  34.7%
23
  45.1%
Right
32
  65.3%
28
  54.9%
Time Frame 1 month following procedure
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Manual Drainage Vacuum Bottle Drainage
Hide Arm/Group Description Patients undergo drainage of pleural fluid via manual (syringe) system

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles

All-Cause Mortality
Manual Drainage Vacuum Bottle Drainage
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Manual Drainage Vacuum Bottle Drainage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      5/51 (9.80%)    
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1 [1]  0/49 (0.00%)  0 3/51 (5.88%)  3
Clinically Significant Pulmonary Edema  2 [2]  0/49 (0.00%)  0 1/51 (1.96%)  1
Hemothorax  3 [3]  0/49 (0.00%)  0 1/51 (1.96%)  1
1
Term from vocabulary, Pneumothorax
2
Term from vocabulary, Pulmonary Edema
3
Term from vocabulary, Hemothorax
Indicates events were collected by systematic assessment
[1]
Pneumothorax as a result of the procedure
[2]
Clinically Significant Pulmonary Edema requiring ventilatory support
[3]
Hemothorax (or bleeding in the thoracic cavity as a result of the procedure)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Manual Drainage Vacuum Bottle Drainage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/51 (0.00%)    
This was a single center study with a modest patient size. There was heterogeneity between the two arms of the study which limits interpretation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jonathan Puchalski, MD
Organization: Yale University School of Medicine
Phone: 2037375699
Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03496987     History of Changes
Other Study ID Numbers: 1511016858
P30AG021342 ( U.S. NIH Grant/Contract )
First Submitted: April 4, 2018
First Posted: April 12, 2018
Results First Submitted: April 13, 2018
Results First Posted: August 31, 2018
Last Update Posted: January 30, 2019