Feasibility Study of the Hemolung Respiratory Assist System

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)

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.

Study Overview

• Status: Completed
• Conditions: Hypercapnic Respiratory Failure, COPD
• Intervention / Treatment: Device: Hemolung Respiratory Assist System

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Artemis Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alung Technologies
• Investigators: Principal Investigator: RK Mani, MD, Artemis Health Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: hypercapnic respiratory failure, COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: HL-CA-2000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes