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Completed

NCT Number: NCT00987740

Feasibility Study of the Hemolung Respiratory Assist System

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.

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Key information

Conditions

Hypercapnic Respiratory Failure, COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Artemis Health Institute

Gurgaon, Haryana, 122001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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

  2. Percentage of patients requiring Mechanical Ventilation

    Time frame: 7 days

Secondary outcomes

  1. Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.

    Time frame: 7 days

  2. Change in Minute Volume (VE) pre- to end-Hemolung therapy

    Time frame: 7 days

  3. Number of days in the ICU

    Time frame: 30 days

  4. Number of days in the hospital

    Time frame: 30 days

  5. 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

  6. Percentage of patients requiring sedation, and hours of sedation

    Time frame: 30 days

  7. Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)

    Time frame: 30 days

  8. For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation

    Time frame: 30 days

  9. Duration of weaning time from NIPPV

    Time frame: 7 days

  10. Duration of weaning time from Hemolung therapy

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Alung Technologies

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2009
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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