Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability

Respiratory Instability Clinical Trial

Official title:

Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436850
• Other study ID #: SOR-0116-15-CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2015
• Last updated: March 15, 2016
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2016
• Source: Soroka University Medical Center
• Contact: Ori Galante, MD
• Phone: +972-50-7577582
• Email: ori.galante[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Instability

Intervention

Procedure:
• Thoracentesis
An invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes.

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (14)

Balik M, Plasil P, Waldauf P, Pazout J, Fric M, Otahal M, Pachl J. Ultrasound estimation of volume of pleural fluid in mechanically ventilated patients. Intensive Care Med. 2006 Feb;32(2):318-21. Epub 2006 Jan 24. — View Citation

Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. — View Citation

Eibenberger KL, Dock WI, Ammann ME, Dorffner R, Hörmann MF, Grabenwöger F. Quantification of pleural effusions: sonography versus radiography. Radiology. 1994 Jun;191(3):681-4. — View Citation

Estenne M, Yernault JC, De Troyer A. Mechanism of relief of dyspnea after thoracocentesis in patients with large pleural effusions. Am J Med. 1983 May;74(5):813-9. — View Citation

Fartoukh M, Azoulay E, Galliot R, Le Gall JR, Baud F, Chevret S, Schlemmer B. Clinically documented pleural effusions in medical ICU patients: how useful is routine thoracentesis? Chest. 2002 Jan;121(1):178-84. — View Citation

Feller-Kopman D, Walkey A, Berkowitz D, Ernst A. The relationship of pleural pressure to symptom development during therapeutic thoracentesis. Chest. 2006 Jun;129(6):1556-60. — View Citation

Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23. — View Citation

Lichtenstein D, Hulot JS, Rabiller A, Tostivint I, Mezière G. Feasibility and safety of ultrasound-aided thoracentesis in mechanically ventilated patients. Intensive Care Med. 1999 Sep;25(9):955-8. — View Citation

Mattison LE, Coppage L, Alderman DF, Herlong JO, Sahn SA. Pleural effusions in the medical ICU: prevalence, causes, and clinical implications. Chest. 1997 Apr;111(4):1018-23. — View Citation

Perazzo A, Gatto P, Barlascini C, Ferrari-Bravo M, Nicolini A. Can ultrasound guidance reduce the risk of pneumothorax following thoracentesis? . J Bras Pneumol. 2014 Jan-Feb;40(1):6-12. doi: 10.1590/S1806-37132014000100002. English, Portuguese. — View Citation

Roch A, Bojan M, Michelet P, Romain F, Bregeon F, Papazian L, Auffray JP. Usefulness of ultrasonography in predicting pleural effusions > 500 mL in patients receiving mechanical ventilation. Chest. 2005 Jan;127(1):224-32. — View Citation

Vignon P, Chastagner C, Berkane V, Chardac E, François B, Normand S, Bonnivard M, Clavel M, Pichon N, Preux PM, Maubon A, Gastinne H. Quantitative assessment of pleural effusion in critically ill patients by means of ultrasonography. Crit Care Med. 2005 Aug;33(8):1757-63. — View Citation

Walden AP, Garrard CS, Salmon J. Sustained effects of thoracocentesis on oxygenation in mechanically ventilated patients. Respirology. 2010 Aug;15(6):986-92. doi: 10.1111/j.1440-1843.2010.01810.x. Epub 2010 Jul 20. — View Citation

Wang LM, Cherng JM, Wang JS. Improved lung function after thoracocentesis in patients with paradoxical movement of a hemidiaphragm secondary to a large pleural effusion. Respirology. 2007 Sep;12(5):719-23. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay		12 months	No
Secondary	Vital signs and wellbeing questionnaire		12 months	No
Secondary	Readmission rates		12 months	No