Trial Outcomes & Findings for Vacuum vs Manual Drainage During Unilateral Thoracentesis (NCT NCT03496987)

NCT ID: NCT03496987

Last Updated: 2023-07-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 5-20 minutes
• Results posted on: 2023-07-14

Participant Flow

Inpatients, who were awake, consentable, and undergoing unilateral thoracentesis

Participant milestones

Measure	Manual Drainage Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Overall Study STARTED	49	51
Overall Study COMPLETED	49	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=51 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles	Total n=100 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 16.2 • n=49 Participants	65.6 years STANDARD_DEVIATION 15.5 • n=51 Participants	67 years STANDARD_DEVIATION 15.8 • n=100 Participants
Sex: Female, Male Female	26 Participants n=49 Participants	22 Participants n=51 Participants	48 Participants n=100 Participants
Sex: Female, Male Male	23 Participants n=49 Participants	29 Participants n=51 Participants	52 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	49 participants n=49 Participants	51 participants n=51 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: 5-20 minutes

Population: 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).

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.

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=50 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Pain Change	0.53 Pre-post NPRS Pain Scale Score Standard Deviation 1.7	1.43 Pre-post NPRS Pain Scale Score Standard Deviation 2.7

SECONDARY outcome

Timeframe: 5-20 minutes

Population: 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).

Actual time of drainage in seconds for each patient.

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=50 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Time of Drainage	498.5 seconds Standard Deviation 386.5	318.6 seconds Standard Deviation 193

SECONDARY outcome

Timeframe: 5-20 minutes

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).

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=51 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Number of Patients Who Had an Early Termination of Procedure	1 Participants	8 Participants

SECONDARY outcome

Timeframe: <7 days

Population: 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).

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)

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=50 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Number of Patients Who Had a Complication as a Result of the Procedure Pneumothorax	0 Participants	3 Participants
Number of Patients Who Had a Complication as a Result of the Procedure Hemothorax	0 Participants	1 Participants
Number of Patients Who Had a Complication as a Result of the Procedure Clinically Significant Pulmonary Edema	0 Participants	1 Participants

SECONDARY outcome

Timeframe: <7 days

Population: 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).

Clinical etiology of effusion

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=50 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Etiology of Effusion Unknown	3 Participants	8 Participants
Etiology of Effusion Malignant	13 Participants	8 Participants
Etiology of Effusion Paramalignant	7 Participants	2 Participants
Etiology of Effusion Heart Failure	7 Participants	8 Participants
Etiology of Effusion Hepatic Hydrothorax	3 Participants	5 Participants
Etiology of Effusion Post-Cardiothoracic Procedure	13 Participants	17 Participants
Etiology of Effusion Parapneumonic	3 Participants	2 Participants

SECONDARY outcome

Timeframe: <20 minutes

Population: 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).

Volume of effusion drained (in mL)

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=50 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Volume of Effusion	1023 milliters Standard Deviation 674	1143 milliters Standard Deviation 775

SECONDARY outcome

Timeframe: <20 minutes

Laterality of effusion (left or right)

Outcome measures

Measure	Manual Drainage n=49 Participants Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=51 Participants Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Laterality of Effusion Left	17 Participants	23 Participants
Laterality of Effusion Right	32 Participants	28 Participants

Adverse Events

Manual Drainage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vacuum Bottle Drainage

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Manual Drainage n=49 participants at risk Patients undergo drainage of pleural fluid via manual (syringe) system	Vacuum Bottle Drainage n=51 participants at risk Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/49 • 1 month following procedure	5.9% 3/51 • Number of events 3 • 1 month following procedure
Respiratory, thoracic and mediastinal disorders Clinically Significant Pulmonary Edema	0.00% 0/49 • 1 month following procedure	2.0% 1/51 • Number of events 1 • 1 month following procedure
Respiratory, thoracic and mediastinal disorders Hemothorax	0.00% 0/49 • 1 month following procedure	2.0% 1/51 • Number of events 1 • 1 month following procedure

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Puchalski, MD

Yale University School of Medicine

Phone: 2037375699

Email: jonathan.puchalski@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place