NCT05424120 - Thoracentesis QI Study | Crick | Crick

Thoracentesis QI Study

N/ACompletedNCT05424120

University of Minnesota102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Pleural Effusion

Interventions

Manual aspirationPROCEDURE

One option from standard of care

Wall suctionPROCEDURE

One option from standard of care

Vacuum bottle drainagePROCEDURE

One option from standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Procedural time to 500mL

Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL

Time frame: Through study completion, an average of 24 hours

Procedural time to 750mL

Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL

Time frame: Through study completion, an average of 24 hours

Procedural time to 1L

Time to pleural fluid drainage from initiation of therapeutic drainage to 1L

Time frame: Through study completion, an average of 24 hours

Pain and dyspnea scores- Baseline

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Time frame: Immediately prior to starting the thoracentesis

Pain and dyspnea scores- Cath

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Time frame: Through study completion, an average of 24 hours

Pain and dyspnea scores- Post-fluid

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Time frame: Through study completion, an average of 24 hours

Pain and dyspnea scores- Post-cath

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Data from ClinicalTrials.gov

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