Respiratory InstabilityNCT02436850
Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability
A study testing Thoracentesis in people with Respiratory Instability, run by Soroka University Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Instability
- What is being tested?
- Thoracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
Ori Galante, MD, ori.galante@gmail.com
About this study
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.
Read the 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.
- Conditions
- Respiratory Instability
- Being tested
- Thoracentesis
- Keywords
- Thoracentesis, Pocket Ultrasound Device, Ultrasound, Soroka University Medical Center, Physical Examination, Ethical Committee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracentesisProcedure or surgery
An invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive large volume thoracentesis. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Measured: 12 months
Secondary outcomes (2)
Vital signs and wellbeing questionnaire
Measured: 12 months
Readmission rates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Respiratory InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Galante, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436850
- Sponsor's protocol ID
- SOR-0116-15-CTIL
- Status last verified
- Mar 2016
- First submitted
- 20 Apr 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11796448Mattison 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.
PubMed 9106583Walden 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.
PubMed 20646244Collins 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.
PubMed 3581930Wang 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.
PubMed 17875061Estenne 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.
PubMed 6837605Jones 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.
PubMed 12576360Perazzo 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.
PubMed 24626264Eibenberger 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.
PubMed 8184046Lichtenstein 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.
PubMed 10501751Balik 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.
PubMed 16432674Vignon 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.
PubMed 16096453Roch 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.
PubMed 15653988Feller-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.
PubMed 16778274
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability
- ClinicalTrials.gov ID
- NCT02436850
- Acronym / sponsor ID
- SOR-0116-15-CTIL
- Conditions
- Respiratory Instability
- Keywords
- Thoracentesis, Pocket Ultrasound Device, Ultrasound, Soroka University Medical Center, Physical Examination, Ethical Committee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: ThoracentesisThe intervention group will receive large volume 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThoracentesisAn invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes. | Procedure or surgery | Intervention group |
Primary outcome
Hospital length of stay
Time frame: 12 months
2 secondary outcomes
Vital signs and wellbeing questionnaire
Time frame: 12 months
Readmission rates
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 11796448Fartoukh 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.
- Background: PubMed 9106583Mattison 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.
- Background: PubMed 20646244Walden 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.
- Background: PubMed 3581930Collins 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.
- Background: PubMed 17875061Wang 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.
- Background: PubMed 6837605Estenne 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.
- Background: PubMed 12576360Jones 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.
- Background: PubMed 24626264Perazzo 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.
- Background: PubMed 8184046Eibenberger 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.
- Background: PubMed 10501751Lichtenstein 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.
- Background: PubMed 16432674Balik 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.
- Background: PubMed 16096453Vignon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracentesis in people with Respiratory Instability, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Galante, MD (+972-50-7577582, ori.galante@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436850, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.