Clinical trial NCT00987740: Feasibility Study of the Hemolung Respiratory Assist System
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnic Respiratory Failure, COPD
Keywords: hypercapnic respiratory failure, COPD
Lead sponsor: Alung Technologies
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
timeFrame: 30 days
measure: Percentage of patients requiring Mechanical Ventilation
timeFrame: 7 days
Secondary outcomes:
measure: Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
timeFrame: 7 days
measure: Change in Minute Volume (VE) pre- to end-Hemolung therapy
timeFrame: 7 days
measure: Number of days in the ICU
timeFrame: 30 days
measure: Number of days in the hospital
timeFrame: 30 days
measure: Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy
timeFrame: 30 days
measure: Percentage of patients requiring sedation, and hours of sedation
timeFrame: 30 days
measure: Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)
timeFrame: 30 days
measure: For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation
timeFrame: 30 days
measure: Duration of weaning time from NIPPV
timeFrame: 7 days
measure: Duration of weaning time from Hemolung therapy
timeFrame: 7 days
Other outcomes:
Locations:
city: Gurgaon
country: India
facility: Artemis Health Institute
state: Haryana
Study officials:
affiliation: Artemis Health Institute
name: RK Mani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.