PleuraFlow Active Clearance Technology System
PleuraFlow technology has been optimized to deliver additional power with the push of a button.
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PleuraFlow ACT Product Information
PleuraFlow® Instructions for Use - English Only
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PleuraFlow® Instructions for Use - English Only:
https://clearflow.com/wp-content/uploads/2024/03/PL055.C-LAYOUT.pdf
Clinical Support
PleuraFlow ACT OR Training Module (TN116-A)
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PleuraFlow ACT OR Training Module (TN116-A):
https://clearcatheter-my.sharepoint.com/:p:/g/personal/jherlofsky_clearflow_com/EYv_U6eD29NDgaxxWtMPqXsBbFWOJ0lEbw7TlyH5qRYv8w?e=ZTQvHC
PleuraFlow ACT ICU Training Module (TN117-A)
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PleuraFlow ACT ICU Training Module (TN117-A):
https://clearcatheter-my.sharepoint.com/:p:/g/personal/jherlofsky_clearflow_com/EWCdhZ7hushLshWGFgrduuQBFQfYZ2mplJb5RCIosTDZEQ?e=cPCabI
PleuraFlow ACT ICU Training Worksheet (TN118-A)
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PleuraFlow ACT ICU Training Worksheet (TN118-A):
https://clearflow.com/wp-content/uploads/2021/06/Gen3-PleuraFlow-ICU-Training-Worksheet-TN118-A.pdf
PleuraFlow ACT System Configuration Guide
Visual representations of common configurations of PleuraFlow and conventional chest tubes with drainage tubing and canister.
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PleuraFlow ACT System Configuration Guide:
https://clearflow.com/wp-content/uploads/2021/07/ConfigurationGuide_5.pdf
PleuraFlow System Assemble
Guide Tube Removal
Magnet Strength Button Activation
Magnetic Release Safety Feature
Channel/Blake Drain Keycard
“The Facts” About Channel/Blake Drains
Updated: November 7, 2017
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Channel/Blake Drain Keycard:
https://clearflow.com/wp-content/uploads/2021/07/ML202-B-ClearFlowKeycard2_Final_10.26.17-1.pdf
Milking & Stripping Keycard
“The Facts” About Milking And Stripping
Updated: November 7, 2017
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Milking & Stripping Keycard:
https://clearflow.com/wp-content/uploads/2021/07/ML201-B-ClearFlowKeycard1_Final_10.23.17-1.pdf
Head of Bed PleuraFlow System Sign
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Head of Bed PleuraFlow System Sign:
https://clearflow.com/wp-content/uploads/2021/07/DC101-C_HOBSign_2020_4.pdf
Head of Bed (Stepdown) PleuraFlow System Sign
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Head of Bed (Stepdown) PleuraFlow System Sign:
https://clearflow.com/wp-content/uploads/2021/07/DC105-C_HOB_StepDown_2020_2.pdf
General Resource Files
Active clearance vs conventional management of chest tubes after cardiac surgery: a randomized controlled study
In this RCT, the implementation of active clearance of chest tubes reduced re-exploration and chest tube clogging in patients after cardiac surgery further supporting recommendations to consider this modality postoperatively. (St-Onge, et al, 2021)
Updated: March 24, 2021
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Active clearance vs conventional management of chest tubes after cardiac surgery: a randomized controlled study:
https://clearflow.com/wp-content/uploads/2021/06/Active-clearance-vs-conventional-management-of-chest-tubes-after-cardiac-surgery-randomized-controlled-study-St-Onge-et-al-JCTS-2021.pdf
Effectiveness of Active Chest Tube Clearance Versus Conventional Chest Tube in Reducing Postoperative Complications After Cardiac Surgery: a Systematic Review and Meta‑analysis
The clinical findings from this systematic review support the usage of ATC (Active Tube Clearance). It also revealed that ATC improves the clinical conditions of cardiac patients and reduces post-surgery complications compared to CT.
Updated: July 15, 2022
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Effectiveness of Active Chest Tube Clearance Versus Conventional Chest Tube in Reducing Postoperative Complications After Cardiac Surgery: a Systematic Review and Meta‑analysis:
https://clearflow.com/wp-content/uploads/2022/11/Hasan-et-al.-Effectiveness-of-active-chest-tube-clearance-versus-conventional-chest-tube-in-reducing-postoperative-complications-2022-1.pdf
Active clearance of chest tubes is associated with reduced postoperative complications and costs after cardiac surgery: a propensity matched analysis
Reduction of patient complications and hospital resource utilization after heart surgery demonstrated with use of the PleuraFlow ACT System. (Baribeau, et al, 2019)
Updated: November 14, 2019
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Active clearance of chest tubes is associated with reduced postoperative complications and costs after cardiac surgery: a propensity matched analysis:
https://clearflow.com/wp-content/uploads/2020/06/Baribeau-Active-clearance-110819-.pdf
Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations
Enhanced Recovery After Surgery (ERAS) evidence-based protocols for perioperative care can lead to improvements in clinical outcomes and cost savings. This article aims to present consensus recommendations for the optimal perioperative management of patients undergoing cardiac surgery. (Daniel T. Engelman, MD, et al, 2019)
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Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations:
https://clearflow.com/wp-content/uploads/2021/07/JAMA-ERAS-Guidelines-May-2019-1-1.pdf
Examining the impact of active clearance of chest drainage catheters on postoperative atrial fibrillation
Postoperative atrial fibrillation (POAF) is one of the most frequent complications encountered after heart surgery, and significantly increases complications and mortality. (St. Onge, et al, 2017)
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Examining the impact of active clearance of chest drainage catheters on postoperative atrial fibrillation:
https://clearflow.com/wp-content/uploads/2021/07/St-Onge-Examining-Impact-Active-Clearance-of-Chest-Drainage-Full-Text-August-2017-JTCVS.pdf
Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation
Chest tubes are utilized to evacuate shed blood after left ventricular assist device (LVAD) implantation, however, they can become clogged, leading to retained blood. We implemented a protocol for active tube clearance (ATC) of chest tubes to determine if this might reduce interventions for retained blood. (Maltais, 2016)
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Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation:
https://clearflow.com/wp-content/uploads/2021/07/Maltais.Active-Clearance-of-Chest-Tubes-Reduces-Re-exploration-for-Bleeding-After-VAD-ASAIO-journal.pdf
Pericardial Blood as a Trigger for Postoperative Atrial Fibrillation After Cardiac Surgery
Prevention strategies have long been sought to reduce the incidence and burden of postoperative atrial fibrillation (POAF) after heart surgery. (St-Onge, 2017)
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Pericardial Blood as a Trigger for Postoperative Atrial Fibrillation After Cardiac Surgery:
https://clearflow.com/wp-content/uploads/2021/07/St.-Onge-et-al-Pericardial-blood-as-a-trigger-for-POAF-after-Cardiac-Surgery-Annals-of-Thoracic-Cx-2018.pdf
Active Chest Tube Clearance After Cardiac Surgery Is Associated With Reduced Reexploration Rates
Active tube clearance is associated with reduced reexploration rates in an all-comers collective undergoing cardiac surgery. Reexploration is the only RBS component relevant for mortality.
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Active Chest Tube Clearance After Cardiac Surgery Is Associated With Reduced Reexploration Rates:
https://clearflow.com/wp-content/uploads/2021/07/Grieshaber.ACT-Clearance-After-Cardiac-Surgery-Assoc-Reduced-Reexploration-Rates.ATS-2018.pdf
Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery
Review of 19 randomized controlled trials published in the Journal of Thoracic and Cardiovascular Surgery. Showed post pericardial drainage is safe and effective technique associated with a reduction in tamponade, early and late pericardial effusions, POAF and hospital stay. These benefits, in turn, translate into improved survival after heart surgery. (Gozdek, 2017)
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Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery:
https://clearflow.com/wp-content/uploads/2021/07/gozdek-meta-analysis-article-1.pdf
Outcome after procedures for retained blood syndrome in coronary surgery
A total of 2764 consecutive patients who underwent isolated CABG from 2006 to 2013 were investigated retrospectively. Conclusion was that patients requiring any procedure for blood removal from pericardial and pleural spaces is associated with an increased risk of severe complications after isolated CABG. (Tauriainen, 2017)
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Outcome after procedures for retained blood syndrome in coronary surgery:
https://clearflow.com/wp-content/uploads/2021/07/Tauriainen.Outcome-After-Procedure-for-RBS-in-Coronary-Surgery-EJCTS-2017.pdf
Impact of Retained Blood Requiring Reintervention on Outcomes After Cardiac Surgery
Study published in Journal of Thoracic and Cardiovascular Surgery which reviewed patient complications in pleural and pericardial cavities after cardiac surgery. Found statistically significant increases in mortality, hospital and ICU LOS, time of ventilation, and incidence of hemolysis in patients with retained blood interventions due to incomplete evacuation of shed blood. (Balzer, 2016)
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Impact of Retained Blood Requiring Reintervention on Outcomes After Cardiac Surgery:
https://clearflow.com/wp-content/uploads/2021/07/Balzer.Impact-of-Retained-Blood-Requiring-Reintervention.JTCVS_.2016.pdf
Tamponade Relief by Active Clearance of Chest Tubes
This is a case report of a patient who developed a tamponade in the ICU while recovering from heart surgery. The tamponade was recognized, and captured on Echo imaging. The patient had a PleuraFlow, so they actuated it a few times, and a clot was removed, and a gush of blood drained. The patient’s condition greatly improved, and the tamponade disappeared on Echo. (Vistarini, 2016)
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Tamponade Relief by Active Clearance of Chest Tubes:
https://clearflow.com/wp-content/uploads/2021/07/Vistarini.Perrault.Tamponade-Relief-by-Active-Clearance-of-CTs-2016.pdf
Retained Blood Syndrome After Cardiac Surgery: A New Look at an Old Problem
Retained post surgical blood, known as Retained Blood Syndrome (RBS), occurs in 1 in 5 patients and results in the need for invasive post-op re-interventions for tamponade and/or hemothorax in the acute setting, pericardial and/or pleural effusions subacutely, or fibrosis in the chronic setting. (Boyle. 2015)
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Retained Blood Syndrome After Cardiac Surgery: A New Look at an Old Problem:
https://clearflow.com/wp-content/uploads/2021/07/Boyle.Retained-Blood-Syndrome-After-Cardiac-Surgery.2015.pdf
Active clearance of chest drainage catheters reduces retained blood
Active tube clearance reduces interventions for retained blood syndrome and postoperative atrial fibrillation, underscoring the importance of maintaining chest tube patency after cardiac surgery. (Sirch. 2015)
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Active clearance of chest drainage catheters reduces retained blood:
https://clearflow.com/wp-content/uploads/2021/07/Sirch.RBS-Nuremberg.JTCVS_.20151.pdf
Hemoglobin-associated oxidative stress in the pericardial compartment of postoperative cardiac surgery patients
Study that showed that retained blood in the pericardium leads to an intense, local pro-oxidant, pro-inflammatory response that may damage the pericardial environment and contribute to the development of POAF. (Kramer.2015)
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Hemoglobin-associated oxidative stress in the pericardial compartment of postoperative cardiac surgery patients:
https://clearflow.com/wp-content/uploads/2021/07/Melby.Hemoglobin-associated-oxidative-stress-1.pdf
Superior Chest Drainage With an Active Tube Clearance System
Evaluation of a Downsized Chest Tube, published in The Annals of Thoracic Surgery (Arakawa. 2010)
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Superior Chest Drainage With an Active Tube Clearance System:
https://clearflow.com/wp-content/uploads/2021/07/Arakawa.Superior-chest-drainage-with-an-active-tube-clearance-system-evaluation-of-a-downsized-chest-tube.2010.pdf
To Strip or Not to Strip?
To Strip or Not to Strip? Physiological Effects of Chest Tube Manipulation, published in the American Journal of Critical Care (Halm. 2007)
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To Strip or Not to Strip?:
https://clearflow.com/wp-content/uploads/2021/07/Halm.To-Strip-or-Not-to-Strip.-Physiological-Effects-of-Chest-Tube-Manipulations.2007.pdf
Incidence of chest tube clogging after cardiac surgery
Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study, published in the European Journal of Cardio-Thoracic Surgery (Karimov. 2013)
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Incidence of chest tube clogging after cardiac surgery:
https://clearflow.com/wp-content/uploads/2021/07/Karimov.Incidence-of-chest-tube-clogging-after-cardiac-surgery-a-single-centre-prospective-observational-study.2013.pdf
Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery
Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery, published in the American Journal of Respiratory and Critical Care Medicine (Light. 2002)
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Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery:
https://clearflow.com/wp-content/uploads/2021/07/Light.-Prevalence-and-Clinical-course-of-pleural-effusion-30-days-after-Coronary-Artery-and-Cardiac-Surgery.2002.pdf
The PleuraFlow Active Chest Tube Clearance System Initial Clinical Experience in Adult Cardiac Surgery
The PleuraFlow Active Chest Tube Clearance System Initial Clinical Experience in Adult Cardiac Surgery, published in the International Society for Minimally Invasive Cardiothoracic Surgery (Perrault. 2012)
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The PleuraFlow Active Chest Tube Clearance System Initial Clinical Experience in Adult Cardiac Surgery:
https://clearflow.com/wp-content/uploads/2021/07/Perrault.The-PleuraFlow-Active-Chest-Tube-Clearance-System.2012.pdf
Chest Tube Selection in Cardiac and Thoracic Surgery
Chest Tube Selection in Cardiac and Thoracic Surgery: A Survey of Chest Tube-Related Complications and Their Management (Shalli. 2009)
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Chest Tube Selection in Cardiac and Thoracic Surgery:
https://clearflow.com/wp-content/uploads/2021/07/Shalli.-Chest-tube-selection-in-cardiac-and-thoracic-surgery.2009.pdf
Improved drainage with active chest tube clearance
Improved drainage with active chest tube clearance, published in Interactive CardioVascular and Thoracic Surgery (Shiose. 2010)
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Improved drainage with active chest tube clearance:
https://clearflow.com/wp-content/uploads/2021/07/Shiose.Improved-Drainage-with-Active-Chest-Tube-Clearance-2010.pdf
Quality Management System to IS EN ISO 13485:2016
ClearFlow, Inc. has been assessed and deemed to comply with the requirements of the above standard in respect of the scope of operations given below: The design, manufacture and distribution of sterile, disposable chest drainage catheters and systems.
Effective Date: July 06, 2024 Expiry Date: July 05, 2027
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Quality Management System to IS EN ISO 13485:2016:
https://clearflow.com/wp-content/uploads/2024/07/MD19.4770-ClearFlow-IS-EN-ISO-13485-2016-Certificate-6-27-24.pdf
MDSAP Certificate
Australia, Brazil, Canada, USA: ClearFlow, Inc. has been assessed and deemed to comply with the requirements of the above standard and regulations in respect of the scope of operations given below: The design, manufacture and distribution of sterile, disposable chest drainage catheters and systems.
Effective Date: July 06, 2024 Expiry Date: July 05, 2027
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MDSAP Certificate:
https://clearflow.com/wp-content/uploads/2024/07/MP19.4770-ClearFlow-Inc-MDSAP-Certificate-6-27-24.pdf
Quality System Approval Certificate Medical Devices Directive 93/42/EEC
CE Marking - CE Quality System Approval Certificate from NSAI for the PleuraFlow System through December 2028.
Effective Date: May 08, 2024 Expiry Date: December 31, 2028
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Quality System Approval Certificate Medical Devices Directive 93/42/EEC:
https://clearflow.com/wp-content/uploads/2024/07/NBCL0091.02-ClearFlow-NB-Confirmation-Letter-252.1078-5-8-24.pdf
What is Retained Blood Syndrome (RBS)?
Retained Blood Syndrome: An Overview
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What is Retained Blood Syndrome (RBS)?:
https://vimeo.com/262444716
Retained Blood Causes & Complications
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Retained Blood Causes & Complications:
https://vimeo.com/474167347
Recovery is Beautiful®
Press Release: FDA Expands Label Indication for PleuraFlow to Reduce Retained Blood
The US FDA has expanded the Indications for Use for the PleuraFlow Active Clearance Technology System to be used in all cardiothoracic surgery and chest trauma procedures for adult and pediatric patients.
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Press Release: FDA Expands Label Indication for PleuraFlow to Reduce Retained Blood:
https://clearflow.com/wp-content/uploads/2021/07/ClearFlowFDApress-ML099-B-6.3.2014-FINAL.pdf
Press Release: Clinical Investigators at German Anesthesia Congress Report Increased Stays in ICU Press Release: Related to Retained Blood Syndrome After Cardiac Surgery
Critical care investigators presented data last week at the 62nd annual German Anesthesia Congress (DAC 2015) in Düsseldorf, Germany about outcomes in patients who develop Retained Blood Syndrome (RBS) from incomplete blood evacuation after cardiac surgery.
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Press Release: Clinical Investigators at German Anesthesia Congress Report Increased Stays in ICU Press Release: Related to Retained Blood Syndrome After Cardiac Surgery:
https://clearflow.com/wp-content/uploads/2021/07/German-Anesthesia-Meeting-DAC-Press-Release-ML098-A-pdf1.pdf
Press Release: Surgeons Discuss High Readmission Rates for Patients with Retained Blood Syndrome After Cardiac Surgery
Leading Clinical Experts Share Experiences at ClearFlow-Hosted Symposium as Company's PleuraFlow® Active Clearance Technology® is displayed at AATS.
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Press Release: Surgeons Discuss High Readmission Rates for Patients with Retained Blood Syndrome After Cardiac Surgery:
https://clearflow.com/wp-content/uploads/2021/07/AATS-2015-Press-Release-ML097-A-pdf.pdf
Study Demonstrates Concern for Retained Blood Syndrome after Heart Surgery
ClearFlow Executives Comment on New Data
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Study Demonstrates Concern for Retained Blood Syndrome after Heart Surgery:
https://clearflow.com/wp-content/uploads/2021/07/BerlinChariteDataAtIARS-FINAL-ML094-A-3.25.2015-.pdf
Press Release: ClearFlow announces positive clinical trial results for the reduction of hospital complications after heart surgery
ClearFlow announces positive clinical trial results for the reduction of hospital complications after heart surgery; Washington, DC.—October 10, 2014—
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Press Release: ClearFlow announces positive clinical trial results for the reduction of hospital complications after heart surgery:
https://clearflow.com/wp-content/uploads/2021/07/FACTS-Care-Press-Release-ML028-A-FINAL-10.6.2014-1.pdf
Value Analysis Committee (VAC) Presentation 2022 – White
Presentation on Reducing Costs and Complications for Your Cardiac Surgery Patients
June 7, 2022
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Value Analysis Committee (VAC) Presentation 2022 – White:
https://clearflow.com/wp-content/uploads/2022/06/VAC-Presentation-Template-White-ML302-A.pptx
Value Analysis Committee (VAC) Presentation 2022 – Branded
Presentation on Reducing Costs and Complications for Your Cardiac Surgery Patients
June 7, 2022
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Value Analysis Committee (VAC) Presentation 2022 – Branded:
https://clearflow.com/wp-content/uploads/2022/06/VAC-Presentation-Template-Branded-ML302-A.pptx
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