This study is currently not recruiting participants.

Expanded Access of Perfluorocarbon (PFC) for use in Broncho-alveolar Lavage for the Treatment of Severe Airway Occlusion in Patients Supported by Extracorporeal Support (ECMO)

Investigating Airway Clearance in Critically Ill Patients with ECMO Support

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The patient is critically ill with disseminated tuberculosis. This has resulted in severe respiratory failure and the need for extracorporeal life support (ECMO). She has had multiple episodes of life-threatening bleeding from her airway and other organs. This airway bleeding and get disease in general have resulted in her airways being clogged by this debris. Nebulized medications have been largely ineffective in clearing the debris, and mechanical removal of the debris has been ineffective and has resulted in more bleeding. If her airways cannot be cleared, she will not achieve lung recovery and will certainly die on ECMO, likely from major hemorrhage due to the need for anticoagulation on ECMO. PFC/PFB/PFD is a substance that is highly dense and has the ability to clear airways of thick debris by instilling it into the airways repeatedly over several days. It has been approved for gentle lavage of the airways in Europe and Canada, and it has been employed in compassionate use and expanded use approvals for this purpose successfully in other institutions in the US. This device has the added benefit of improved oxygenation to the patient, as it is a superb oxygen carrier.

Detailed description of study

The patient is critically ill with disseminated tuberculosis. This has resulted in severe respiratory failure and the need for extracorporeal life support (ECMO). She has had multiple episodes of life-threatening bleeding from her airway and other organs. This airway bleeding and get disease in general have resulted in her airways being clogged by this debris. Nebulized medications have been largely ineffective in clearing the debris, and mechanical removal of the debris has been ineffective and has resulted in more bleeding. If her airways cannot be cleared, she will not achieve lung recovery and will certainly die on ECMO, likely from major hemorrhage due to the need for anticoagulation on ECMO. PFC/PFB/PFD is a substance that is highly dense and has the ability to clear airways of thick debris by instilling it into the airways repeatedly over several days. It has been approved for gentle lavage of the airways in Europe and Canada, and it has been employed in compassionate use and expanded use approvals for this purpose successfully in other institutions in the US. This device has the added benefit of improved oxygenation to the patient, as it is a superb oxygen carrier.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Severe Airway Occlusion
  • Age: 100 years or below
  • Gender: All

This study investigates a method to clear blocked airways in patients who are critically ill with severe respiratory failure due to disseminated tuberculosis. These patients often require extracorporeal life support, or ECMO, a machine that helps with breathing and heart function. The purpose of this study is to explore the use of a dense substance, referred to as PFC/PFB/PFD, which can be instilled into the airways to help remove thick debris that blocks them. This substance has been used in other countries and in some U.S. hospitals with special permissions, and it also helps improve oxygen levels in the body.

Participants in this study will receive repeated treatments with the PFC/PFB/PFD substance over several days. This process is known as lavage, which means washing out the airways to remove debris. The study aims to determine if this method can effectively clear the airways and improve lung recovery, reducing the risk of bleeding that can occur with other treatments.

  • Who can participate: The study is seeking participants who are critically ill with widespread tuberculosis and are receiving ECMO support. Candidates should have persistent airway blockages that have not responded to other treatments. There are no age restrictions for participation.
  • Study details: Participants will undergo a procedure where a dense liquid is used to wash out their airways to remove thick debris. This liquid also helps carry oxygen, which can improve breathing. A placebo will not be used in this study.
Updated on 19 Feb 2024. Study ID: 1809339161

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