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Feasibility Study of the Hemolung Respiratory Assist System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987740
First Posted: October 1, 2009
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alung Technologies
  Purpose
The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory Assist System in patients with hypercapnic respiratory failure associated with acute exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure of noninvasive positive pressure ventilation leading to intubation and mechanical ventilation.

Condition Intervention
Hypercapnic Respiratory Failure, COPD Device: Hemolung Respiratory Assist System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in COPD Patients With Acute Respiratory Failure That Are at a 50% Risk of Failing Non Invasive Ventilation (NIV)

Resource links provided by NLM:


Further study details as provided by Alung Technologies:

Primary Outcome Measures:
  • Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation. [ Time Frame: 30 days ]
  • Percentage of patients requiring Mechanical Ventilation [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy. [ Time Frame: 7 days ]
  • Change in Minute Volume (VE) pre- to end-Hemolung therapy [ Time Frame: 7 days ]
  • Number of days in the ICU [ Time Frame: 30 days ]
  • Number of days in the hospital [ Time Frame: 30 days ]
  • Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy [ Time Frame: 30 days ]
  • Percentage of patients requiring sedation, and hours of sedation [ Time Frame: 30 days ]
  • Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV) [ Time Frame: 30 days ]
  • For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation [ Time Frame: 30 days ]
  • Duration of weaning time from NIPPV [ Time Frame: 7 days ]
  • Duration of weaning time from Hemolung therapy [ Time Frame: 7 days ]

Enrollment: 2
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ventilation and then the Hemolung. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate or severe COPD, as defined by the GOLD criteria
  • Acute exacerbation of COPD (sustained worsening of patient's condition necessitating a change in regular medication)
  • 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
  • Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O)
  • Hemodynamically stable (mean arterial pressure > 65 mmHg without vasopressor support)
  • 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

Exclusion Criteria:

  • 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
  • Received an organ transplant other than corneal transplants
  • Received or currently receiving immunosuppressive therapy, excluding corticosteroids within the last 3 months
  • Presence of severe renal or liver failures
  • Known vascular abnormality with could complicate or prevent successful insertion of the vascular access catheter in the right femoral vein
  • Presence of another catheter in the right femoral vein that cannot be moved
  • Presence of an inferior vena cava filter
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00987740


Locations
India
Artemis Health Institute
Gurgaon, Haryana, India, 122001
Sponsors and Collaborators
Alung Technologies
Investigators
Principal Investigator: RK Mani, MD Artemis Health Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alung Technologies
ClinicalTrials.gov Identifier: NCT00987740     History of Changes
Other Study ID Numbers: HL-CA-2000
First Submitted: September 30, 2009
First Posted: October 1, 2009
Last Update Posted: August 10, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Alung Technologies:
hypercapnic respiratory failure, COPD

Additional relevant MeSH terms:
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms