Thoracentesis QI Study

NCT ID: NCT05424120

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-06-30

Brief Summary

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Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.

Detailed Description

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Conditions

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Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled, non-blinded, single-center, quality improvement study to determine which method of standard of care thoracentesis (wall suctioning, manual aspiration, or vacuum drainage) has the shortest procedural time.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual aspiration

pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock

Group Type ACTIVE_COMPARATOR

Manual aspiration

Intervention Type PROCEDURE

One option from standard of care

Wall suction

pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously

Group Type ACTIVE_COMPARATOR

Wall suction

Intervention Type PROCEDURE

One option from standard of care

Vacuum bottle drainage

pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container

Group Type ACTIVE_COMPARATOR

Vacuum bottle drainage

Intervention Type PROCEDURE

One option from standard of care

Interventions

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Manual aspiration

One option from standard of care

Intervention Type PROCEDURE

Wall suction

One option from standard of care

Intervention Type PROCEDURE

Vacuum bottle drainage

One option from standard of care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>18
* Evidence of pleural effusion on imaging
* Clinical indication for thoracentesis

Exclusion Criteria

* Age \<18
* Standard contraindication for thoracentesis procedure
* Patients on positive pressure ventilation
* Patients who have opted out of research in EPIC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roy Cho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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PACCS-2021-30297

Identifier Type: -

Identifier Source: org_study_id

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