Extracorporeal CO2 Removal With The Hemolung RAS For Mechanical Ventilation Avoidance During Acute Exacerbation Of COPD (VENT-AVOID)

Overview

About this study

There are currently no devices approved in the United States for providing continuous, temporary, extracorporeal carbon dioxide removal (ECCO2R). Although such devices have approvals outside of the United States, there have been no pivotal randomized, controlled trials (RCT) that have scientifically validated the safety and efficacy of ECCO2R for any potential indication. A primary potential indication is for acute hypercapnic respiratory failure in patients experiencing an acute exacerbation of COPD.
This study is being conducted under an FDA approved IDE to establish the safety and efficacy of an investigational Class III medical device for FDA pre-market approval (PMA) via a pivotal RCT to scientifically validate the indication for its use in acute exacerbation of COPD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

1. Age ≥ 40 years
2. Diagnosis of COPD based on previous documented diagnosis of COPD (GOLD Grades 1-4), or ACOS (Asthma-COPD Overlap Syndrome), supported with spirometry (FEV1/FVC < 0.70), as defined by GOLD Criteria [25, 26].

3. Experiencing acute hypercapnic respiratory failure
4. Informed consent from patient or legally authorized representative
5. Meets one of the three following criteria:
A. Is at high risk of requiring intubation and invasive mechanical ventilation (MV) after at least one hour on NIV due to one or more of the following:
− Respiratory acidosis (arterial pH ≤ 7.25, or venous pH ≤ 7.22) despite NIV, worsening or not improving
− Worsening hypercapnia or respiratory acidosis relative to baseline blood gases

No improvement in PaCO2 (or PvCO2) relative to baseline blood gases and presence of moderate or severe dyspnea
− Presence of tachypnea > 30 breaths per minute
− Intolerance of NIV with failure to improve or worsening acidosis, dyspnea, or work of breathing

NOTE: If a patient is receiving intermittent noninvasive support (i.e. alternating BiPAP/CPAP with high-flow nasal cannula) due to BiPAP/CPAP intolerance, this condition meets the above inclusion criterion if the patient is worsening and at high risk of being intubated
OR
B. After starting NIV with a baseline arterial pH ≤ 7.25 (or venous pH ≤ 7.22), shows signs of progressive clinical decompensation manifested by decreased mental capacity, inability to tolerate NIV, or increased or decreased respiratory rate in setting of worsened or unchanged acidosis.
OR
C. Currently intubated and receiving Invasive MV, meeting both of the following:
− Intubated for ≤ 5 days (to time of consent), AND
− Has failed an SBT OR is deemed not suitable for an SBT OR is deemed not suitable for extubation

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Closed for enrollment

More information

Publications

Hypercapnic respiratory failure in patients with COPD frequently requires mechanical ventilatory support. Extracorporeal CO2 removal (ECCO2R) techniques have not been systematically evaluated in these patients. Read More on PubMed

Clinical Trials