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Completed

NCT Number: NCT05424120

Thoracentesis QI Study

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.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual aspiration

Procedure

One option from standard of care

Wall suction

Procedure

One option from standard of care

Vacuum bottle drainage

Procedure

One option from standard of care

Primary outcomes

  1. Procedural time to 500mL

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

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

  2. Procedural time to 750mL

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

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

  3. Procedural time to 1L

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

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

  4. Pain and dyspnea scores- Baseline

    Time frame: Immediately prior to starting the thoracentesis

    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)

  5. Pain and dyspnea scores- Cath

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

    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)

  6. Pain and dyspnea scores- Post-fluid

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

    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)

  7. Pain and dyspnea scores- Post-cath

    Time frame: Immediately after removing the thoracentesis catheter

    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)

  8. Pain and dyspnea scores- 5m post

    Time frame: 5 minutes post-procedure

    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)

  9. Pain and dyspnea scores- 24h post

    Time frame: 24 hours post-procedure

    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)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Thoracentesis Quality Improvement (QI) Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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