Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability

NCT02436850 | Unknown

• 1 other identifier: SOR-0116-15-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Instability

Keywords

Thoracentesis; Pocket Ultrasound Device; Ultrasound; Soroka University Medical Center; Physical Examination; Ethical Committee

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  12 months

Secondary Outcomes (2)

• Vital signs and wellbeing questionnaire

  12 months

• Readmission rates

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive large volume thoracentesis.

Procedure: Thoracentesis

Control group

NO INTERVENTION

The control group will be taped with an 18 gauge and 20 gauge venflons and drain will not be placed.

Interventions

Thoracentesis PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Related Publications (14)

• 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. doi: 10.1378/chest.121.1.178.

  PMID: 11796448 BACKGROUND

• 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. doi: 10.1378/chest.111.4.1018.

  PMID: 9106583 BACKGROUND

• 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.

  PMID: 20646244 BACKGROUND

• Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. doi: 10.1378/chest.91.6.817.

  PMID: 3581930 BACKGROUND

• 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. doi: 10.1111/j.1440-1843.2007.01124.x.

  PMID: 17875061 BACKGROUND

• 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. doi: 10.1016/0002-9343(83)91072-0.

  PMID: 6837605 BACKGROUND

• 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. doi: 10.1378/chest.123.2.418.

  PMID: 12576360 BACKGROUND

• 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.

  PMID: 24626264 BACKGROUND

• Eibenberger KL, Dock WI, Ammann ME, Dorffner R, Hormann MF, Grabenwoger F. Quantification of pleural effusions: sonography versus radiography. Radiology. 1994 Jun;191(3):681-4. doi: 10.1148/radiology.191.3.8184046.

  PMID: 8184046 BACKGROUND

• Lichtenstein D, Hulot JS, Rabiller A, Tostivint I, Meziere G. Feasibility and safety of ultrasound-aided thoracentesis in mechanically ventilated patients. Intensive Care Med. 1999 Sep;25(9):955-8. doi: 10.1007/s001340050988.

  PMID: 10501751 BACKGROUND

• 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. doi: 10.1007/s00134-005-0024-2. Epub 2006 Jan 24.

  PMID: 16432674 BACKGROUND

• Vignon P, Chastagner C, Berkane V, Chardac E, Francois 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. doi: 10.1097/01.ccm.0000171532.02639.08.

  PMID: 16096453 BACKGROUND

• 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. doi: 10.1378/chest.127.1.224.

  PMID: 15653988 BACKGROUND

• 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. doi: 10.1378/chest.129.6.1556.

  PMID: 16778274 BACKGROUND

MeSH Terms

Interventions

Thoracentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ori Galante, MD

CONTACT

+972-50-7577582; ori.galante@gmail.com

Lior Fuchs, MD

CONTACT

+972-53-5221565; liorfuchs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ori Galante

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 7, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

IL (1)