Feasibility Study of the Hemolung Respiratory Assist System (Germany)
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|ClinicalTrials.gov Identifier: NCT01021605|
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypercapnic Respiratory Failure, COPD, ARDS||Device: Hemolung Respiratory Assist System||Not Applicable|
The objective of the feasibility study is to evaluate the safety and efficacy of the Hemolung RAS in patients with hypercapnic respiratory failure in five groups of patients:
Group 1: COPD patients with an acute exacerbation and have a 50% likelihood of failure of noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical ventilation
Group 2: Patients with hypercapnic respiratory failure on invasive mechanical ventilation who have either:
- Failed two or more weaning attempts OR
- Failed one or more weaning attempts and do not wish to be invasively mechanically ventilated.
Group 3: Patients with hypercapnic respiratory failure on noninvasive positive pressure ventilation who have failed two weaning attempts and do not wish to be invasively mechanically ventilated.
Group 4: Patients with hypercapnic respiratory failure who in the view of the treating physician are declining on optimized non-invasive positive pressure ventilation OR demonstrate a complete intolerance of non-invasive positive pressure ventilation for any reason and invasive mechanical ventilation is considered undesirable by the treating physician.
Group 5: Patients who are currently invasively mechanically ventilated and in the view of the treating physician would benefit from the application of protective lung ventilation, and in whom this cannot be achieved without significant worsening of respiratory failure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Experimental: Hemolung Respiratory Assist System||
Device: Hemolung Respiratory Assist System
Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive or invasive ventilation and then the Hemolung RAS. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
- The ability of the Hemolung to remove a minimum of 50 mL/min of CO2 for up to seven days and reliable performance of the device over the length of use [ Time Frame: 7 days ]
- The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy. [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021605
|Thoraxklinik am Universitätsklinikum Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, 69126|
|Ruhrlandklinik Das Lungenzentrum Essen-Heidhausen Abt.: Pneumologie|
|Essen, Nordrhein-Westfalen, Germany, 45122|
|Donaustauf, Germany, 93093|
|Göttingen, Germany, D-37077|
|Asklepios Klinik Barmbek|
|Hamburg, Germany, 22291|
|Solingen, Germany, 42699|
|Principal Investigator:||Felix JF Herth, MD||Thoraxklinik-Heidelberg gGmbH|