Feasibility Study of the Hemolung Respiratory Assist System (Germany)

NCT01021605 | Completed DMC

• 1 other identifier: HL-CA-1000
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) in patients with hypercapnic respiratory failure.

Conditions

Hypercapnic Respiratory Failure, COPD, ARDS

Keywords

hypercapnic respiratory failure, COPD, ARDS

Outcome Measures

Primary Outcomes (2)

• 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

  7 days

• The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy.

  30 days

Study Arms (1)

Hemolung Respiratory Assist System

EXPERIMENTAL

Device: Hemolung Respiratory Assist System

Interventions

Hemolung Respiratory Assist System DEVICE

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.

Hemolung Respiratory Assist System

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed hypercapnic respiratory failure (PaCO2 \>50mmHg(6.7kPa)) and falling into one of the five groups
• Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O)
• Hemodynamically stable: Mean arterial pressure (MAP) \> 65 mmHg without vasopressor support, or MAP \> 60 mmHg with a requirement for vasopressor support that can be attributed to sedation or dynamic hyperinflation resulting from mechanical ventilation by the treating investigator.
• Chronic arrhythmias (e.g., atrial fibrillation) well controlled
• Minimum platelet count of 100,000/mm3
• Minimum red blood cell count of 2.5 mill/μl
• Group 1:
• Known or suspected severe COPD, as defined by the GOLD criteria
• On non-invasive positive pressure mechanical ventilation \> 1hour with either:
• PaCO2 \> 55 mmHg with pH \< 7.25 OR
• PaCO2 \> 55 mmHg with \< 5mmHg decrease from baseline and pH \< 7.30
• Group 2:
• Intubated or tracheostomized patients with hypercapnic respiratory failure who either:
• Has failed at least 2 weaning attempts or
• Has failed at least 1 attempt and wishes not to be invasively mechanically ventilated

You may not qualify if:

• Presence of acute, uncontrolled arrhythmia
• Acute ischemic heart disease
• Presence of bleeding diathesis
• Significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder
• Recent (\< 7 days) prolonged (\>24 hrs) use of muscle paralyzing agents
• Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation
• Coma from any cause, or decreased consciousness
• Hypersensitivity to heparin or previous heparin induced thrombocytopenia
• Recent (\< 6 months) major chest abdominal trauma or surgery
• Presence of septic shock
• Presence of a significant pneumothorax or bronchopleural fistula
• History of uncontrolled major psychiatric disorder
• Pregnant women
• Known to have AIDS or to have symptomatic HIV
• Received chemotherapy or radiation within the previous 90 days

Sponsors & Collaborators

• Alung Technologies: lead

Study Sites (7)

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Ruhrlandklinik Das Lungenzentrum Essen-Heidhausen Abt.: Pneumologie

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Klinik Donaustauf

Donaustauf, 93093, Germany

Location

Universitätsmedizin Göttingen

Göttingen, D-37077, Germany

Location

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

Location

Krankenhaus Bethanien

Solingen, 42699, Germany

Location

Related Publications (1)

• Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.

  PMID: 23460154 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felix JF Herth, MD

  Thoraxklinik-Heidelberg gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

DE (7)