Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability

March 15, 2016 updated by: Ori Galante, Soroka University Medical Center
The purpose of the trial is to evaluate the effectiveness of moderate to large volume thoracentesis (TC) in non-ventilated patients in Internal Medicine admitted due to, or suffer from respiratory instability. This is a prospective, double-center, randomized clinical trial. This is a stage 1 pilot trial aimed to provide better understanding on the study population and study groups. This trial will comprise a total of 60 patients, 30 subjects on the intervention group and an equal number on the control group. The results of this pilot trial will be to design a larger trial and calculate a required sample size.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prevalence of pleural effusion is high among medical patients, reaching 62% among Medical ICU patients. Often clinicians are standing in front of a symptomatic respiratory patient with moderate or large pleural effusion. The clinical question whether TC will be beneficial for the patient with respiratory compromise is yet to be shown. There are few, small scale studies on the benefit of pleural effusion thoracentesis. Only one study found sustained effect of thoracentesis on oxygenation among 10 patients on mechanical ventilation. Lung function was found to improve after TC among patients with paradoxical movement of hemidiaphragm, and relief of dyspnea after large pleural effusion TC was demonstrated as well. No study to date, as the investigators know, on the benefit of TC, was done on non-ventilated, ward patients with moderate to large pleural effusion. Also, no studies to date showed any improved clinical outcome of this procedure.

Although ultrasound guided TC is a safer mode than blinded TC, complications as pneumothorax, pain, shortness of breath, cough, bleeding, hematoma, and re-expansion pulmonary edema may result from TC. Although no consensus exist regarding the benefit of TC still this procedure is common among ventilated and non-ventilated patients. The investigators seek to find whether there is clinical benefit for TC, among non-ventilated, ward patients with moderate to large pleural effusion. For this purpose the investigators aim to conduct a prospective randomized trial.

In this study the investigators aim to compare outcomes as: hospital length of stay, vital signs and wellbeing, utilization of imaging modalities and readmission rates among patients who had therapeutic TC compared to those who had not. Also the investigators would like to try and predict the amount of pleural effusion from the ultrasound imaging as well as to find the added value of point of care US screening of pleural effusion on top of routine Xr among patients with respiratory instability.

To the best of the investigators' knowledge, no prospective randomized study to date has compared the strategy of TC to none among non-ventilated ward patients with respiratory complains.

This is a prospective, double-center, randomized clinical trial. This is a stage 1 pilot trial aimed to provide better understanding on the study population and study groups. This trial will comprise a total of 60 patients, 30 subjects on the intervention group and an equal number on the control group. The results of this pilot trial will be to design a larger trial and calculate a required sample size.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients admitted to internal ward
  2. Patients with moderate to large pleural effusion per ultrasound as defined under Eligibility section below

  3. At least of the following findings:

    • Dyspnea on admission notes
    • Tachypnea (RR >18 pm)
    • Desaturation (saturation<88%)
    • Admission diagnosis of CHF exacerbation or any uncontrolled heart failure,
    • Effort dyspnea per history,
    • Acute or subacute (last two weeks) need for oxygen supplement or Noninvasive ventilation.
    • Admission diagnosis of pulmonary edema or pulmonary congestion
    • Hypoxemia (PaO2<60mmHg)
    • Pleuritic chest pain

Exclusion Criteria:

  1. Subject currently enrolled in another investigational study
  2. Patients on mechanical ventilation
  3. Patients with coagulopathy (known or with any prolongation of PTT, PT, fibrinogen<200, platelets <100000)
  4. Patients with cognitive impairment who cannot sign informed consent
  5. Patients with sepsis or fever and pneumonia and suspected empyema
  6. Patients with any previous surgeries to the lungs
  7. Patients whom the primary team call for therapeutic TC.
  8. Patients with less than moderate amount of pleural effusion (see Eligibility criteria)
  9. Palliative patients
  10. Pregnant patients
  11. On any current anticoagulation therapy or with any abnormal coagulation study.
  12. Patients with septations or cavitation in pleural space (visible on US

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The intervention group will receive large volume thoracentesis.
Procedure: Thoracentesis
An invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes.
No Intervention: Control group
The control group will be taped with an 18 gauge and 20 gauge venflons and drain will not be placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs and wellbeing questionnaire
Time Frame: 12 months
12 months
Readmission rates
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SOR-0116-15-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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