NCT03496987

Vacuum vs Manual Drainage During Unilateral Thoracentesis

Completed NA Results posted Last updated 14 July 2023

What this trial tests

NA trial testing Vacuum Bottle Drainage in Pleural Effusion in 100 participants. Completed in 1 March 2018.

Timeline

1 December 2015

Primary endpoint
30 September 2017

1 March 2018

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 December 2015
Primary completion	30 September 2017
Estimated completion	1 March 2018

Drugs / interventions tested

• Vacuum Bottle Drainage

Conditions studied

• Pleural Effusion — all drugs for Pleural Effusion →
• Pleural Diseases — all drugs for Pleural Diseases →
• Thoracic Diseases — all drugs for Thoracic Diseases →

Sponsor

Yale University

Who can join

Adults 18 to 99, any sex, with Pleural Effusion or Pleural Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Change Primary · 5-20 minutes

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.

Group	Value	95% CI
Manual Drainage	0.53	± 1.7
Vacuum Bottle Drainage	1.43	± 2.7

Time of Drainage Secondary · 5-20 minutes

Actual time of drainage in seconds for each patient.

Group	Value	95% CI
Manual Drainage	498.5	± 386.5
Vacuum Bottle Drainage	318.6	± 193

Number of Patients Who Had an Early Termination of Procedure Secondary · 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).

Group	Value	95% CI
Manual Drainage	1
Vacuum Bottle Drainage	8

Number of Patients Who Had a Complication as a Result of the Procedure Secondary · <7 days

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)

Pneumothorax

Group	Value	95% CI
Manual Drainage	0
Vacuum Bottle Drainage	3

Hemothorax

Group	Value	95% CI
Manual Drainage	0
Vacuum Bottle Drainage	1

Clinically Significant Pulmonary Edema

Group	Value	95% CI
Manual Drainage	0
Vacuum Bottle Drainage	1

Etiology of Effusion Secondary · <7 days

Clinical etiology of effusion

Malignant

Group	Value	95% CI
Manual Drainage	13
Vacuum Bottle Drainage	8

Paramalignant

Group	Value	95% CI
Manual Drainage	7
Vacuum Bottle Drainage	2

Heart Failure

Group	Value	95% CI
Manual Drainage	7
Vacuum Bottle Drainage	8

Hepatic Hydrothorax

Group	Value	95% CI
Manual Drainage	3
Vacuum Bottle Drainage	5

Post-Cardiothoracic Procedure

Group	Value	95% CI
Manual Drainage	13
Vacuum Bottle Drainage	17

Parapneumonic

Group	Value	95% CI
Manual Drainage	3
Vacuum Bottle Drainage	2

Unknown

Group	Value	95% CI
Manual Drainage	3
Vacuum Bottle Drainage	8

Volume of Effusion Secondary · <20 minutes

Volume of effusion drained (in mL)

Group	Value	95% CI
Manual Drainage	1023	± 674
Vacuum Bottle Drainage	1143	± 775

Laterality of Effusion Secondary · <20 minutes

Laterality of effusion (left or right)

Group	Value	95% CI
Manual Drainage	17
Vacuum Bottle Drainage	23
Manual Drainage	32
Vacuum Bottle Drainage	28

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month following procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Manual Drainage

Serious: 0/49 (0%)

Deaths: 0/49

Vacuum Bottle Drainage

Serious: 5/51 (10%)

Deaths: 0/51

Serious adverse events (3 terms)

Reaction	System	Manual Drainage	Vacuum Bottle Drainage
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Clinically Significant Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	—	—
Hemothorax	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Pneumothorax, Clinically Significant Pulmonary Edema, Hemothorax.

Data from ClinicalTrials.gov NCT03496987 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.