Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The purpose of this study to determine the safety and effectiveness of a mechanical device to remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease (COPD)when they are hospitalized in the intensive care unit for exacerbation of their condition.
Detailed description
This is a pilot study to examine the efficacy and safety of an extracorporeal circuit to remove carbon dioxide (CO2) from the blood in patients with an acute exacerbation of COPD resulting in acute or acute on chronic respiratory failure. The extracorporeal circuit consists of venovenous configuration through a percutaneously inserted 18 F double lumen catheter placed in a central vein. Centrifugal pump and heparin bonded circuit are used and patient is heparinized to maintain an activated clotting time (ACT) \> 180. Circuit blood flow and gas sweep speed will be adjusted to maximize CO2 removal and minimize ventilator settings and patient's work of breathing. Patients will remain on the extracorporeal circuit for a maximum of four days as tolerated. Plasma Hemoglobin will be monitored daily.
Interventions
DEVICEVenovenous CO2 Removal (VVCO2R) in COPD
Patients who meet criteria will be placed on an extracorporeal circuit consisting of an oxygenator, centrifugal pump, tubing and indwelling double lumen venous catheter for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute respiratory failure on invasive mechanical ventilation or 2. Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation 3. Established diagnosis of COPD 4. Age group: 18 years or greater
Exclusion criteria
1. Significant vasopressor support 2. Systolic BP \< 100 torr systolic despite vasopressor support 3. Class III or Class IV congestive heart failure 4. Left ventricular ejection fraction \< 30% by previous echocardiogram 5. Recent (6 month) history of myocardial infarction 6. Coronary artery disease with unstable angina 7. Recent (6 month) history of venous embolism 8. Uncontrolled coagulopathy (international normalized ratio (INR) \> 5 or activated partial thromboplastin time (aPTT) \> 80s) despite corrective therapy 9. History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only) 10. Pregnancy 11. Severe chronic liver disease 12. Severe anemia (Hgb \< 9 gm/dl) 13. Any contraindication to systemic anticoagulation with heparin, including recent central nervous system injury or hemorrhage, retinal hemorrhage or other recent hemorrhage from sites which cannot be controlled 14. Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.) 15. Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow | 0 to 96 hours | The amount of CO2 removed in cc/min will be recorded. The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VVCO2R in COPD All patients enrolled in the trial will receive the proposed intervention
Rotaflow centrifugal pump (Maquet, Inc.): Patients who meet criteria will be placed on an extracorporeal device for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | VVCO2R in COPD |
|---|---|
| Age, Continuous | 42 years |
| chronic obstructive pulmonary disease (COPD) patients | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
The amount of CO2 removed in cc/min will be recorded. The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded
Time frame: 0 to 96 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VVCO2R in COPD | The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow | 75 cc/min |