Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability
NCT ID: NCT02436850
Last Updated: 2016-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-08-31
2017-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion
NCT06434324
Bronchoscopy for Thoracic Trauma Patients
NCT06264856
Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study
NCT05702580
Pleural Irrigation With a Novel Devise.
NCT06727578
Fibrinolytic Therapy Versus Medical Thoracoscopy
NCT03213834
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
The intervention group will receive large volume thoracentesis.
Thoracentesis
An invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes.
Control group
The control group will be taped with an 18 gauge and 20 gauge venflons and drain will not be placed.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thoracentesis
An invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soroka University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ori Galante
Dr. Ori Galante
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soroka University Medical Center
Beersheba, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SOR-0116-15-CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.