ecco2R to facilitatE earLy libEration From mechanicAl Ventilation inpatientS With Copd Acute Exacerbation

NCT04147104 | Unknown DMC

• 1 other identifier: 2019/53-UCI-HUSC
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

A pragmatic randomised controlled trial to determine whether early Veno-Venous Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) in mechanically ventilated patients with acute exacerbated Chronic Obstructive Pulmonary Disease decreases the days of invasive mechanical ventilation.

Conditions

Acute Exacerbation of COPD

Outcome Measures

Primary Outcomes (1)

• The amount of time in the first 28 days following randomization that a patient is free of ventilatory support including non-invasive ventilation

  Statistically analyzed as Ventilator-Free Days during the 28 days from randomization (VFD-28)

  28 days

Secondary Outcomes (15)

• All-cause (health-related) mortality at 28 and 90 days from randomization

  28 and 90 days

• Health-related quality of life (HRQoL)

  90 days after randomization

• Catheter-related complications

  Participants will be followed for the duration of ICU stay, an expected average of 30 days

• Work of breathing

  Participants will be followed for the duration of ICU stay, an expected average of 4 days

• Time to ECCO2R cessation

  Participants will be followed for the duration of ICU stay, an expected average of 4 days

Study Arms (2)

Standard-of-care plus invasive mechanical ventilation

ACTIVE COMPARATOR

Invasive mechanical ventilation for lung support and to facilitate exhalation via an endotracheal tube o tracheotomy.

Device: Invasive mechanical ventilation

ECCO2R plus invasive mechanical ventilation

EXPERIMENTAL

Low-flow ECCO2R adjunct to standard-of-care and invasive mechanical ventilation.

Device: Low flow ECCO2R; Device: Invasive mechanical ventilation

Interventions

Low flow ECCO2R DEVICE

Treatment with a medical device called ECCO2R. The device consists of a drainage cannula placed in a large central vein, a membrane lung (artificial gas exchanger), and a return cannula into the venous system. Blood is pumped through the membrane lung, and CO2 is removed by diffusion. A flowing gas known as "sweep gas" containing little or no CO2 runs along the other side of the membrane, ensuring a diffusion gradient from blood to the other side, hence promoting CO2 removal.

ECCO2R plus invasive mechanical ventilation

Invasive mechanical ventilation DEVICE

Invasive mechanical ventilation deviceto support acute respiratory failure and facilitate exhalation via an endotracheal tube or tracheotomy.

ECCO2R plus invasive mechanical ventilation; Standard-of-care plus invasive mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Known or suspected aeCOPD that failed NIV that requires invasive mechanical ventilation
• Failed treatment with NIV defined as:
• NIV for at least 2 hours and no more than 24 hours with signs of respiratory distress (respiratory rate \> 30 breaths/min and use of accessory muscles or paradoxical abdominal movements) AND
• PaCO2\> 55 mmHg and pH \< 7.25 or pH \< 7.30 and PaCO2 \> 55 mmHg, with PaCO2 decrease \< 20% from baseline
• Known or suspected aeCOPD patients where NIV is contraindicated and need immediate invasive mechanical ventilation due to:
• Respiratory arrest
• Inability to protect the airway (impaired cough or swallowing or massive aspiration or respiratory pauses with loss of consciousness or gasping of air)
• Inability to clear secretions
• Agitated and confused patients
• Facial deformities or conditions that prevent mask from fitting
• Uncooperative or unmotivated patients

You may not qualify if:

• Participation in other interventional studies
• Patients already included in this study that need a new readmission because of a new aeCOPD episode
• aeCOPD intubated \> 12 hours
• Extubation within the previous 48 hours following intubation and invasive mechanical ventilation due to any cause
• Anatomical abnormalities or vascular diseases preventing the correct insertion of the ECCO2R cannula
• PaO2 to FiO2 ratio \< 150 on PEEP ≥ 5 cmH2O
• Known or suspected pregnancy (women of childbearing potential require a pregnancy test)
• Hemodynamic instability defined as
• MAP \< 60 mmHg despite the infusion of fluids or vasoactive drugs OR
• Failure to increase systolic blood pressure above 80-90 mmHg OR
• Need for inotropic drugs to maintain systolic blood pressure\> 85 mmHg OR
• ECG evidence of ischemia or significant uncontrolled ventricular arrhythmia
• Acute multiple organ failure defined as more than two organ failures assessed by SOFA score. Organ dysfunction can be identified as an acute change in total SOFA score \> 2 points
• Decompensated heart failure defined as an exacerbation of symptoms or signs after a period of relative stability such as dyspnea, fatigue or edema in the setting of previously established myocardial dysfunction (systolic or diastolic)32 and B-natriuretic peptide more than100 ng/L.
• Tracheostomized patients

Sponsors & Collaborators

• Hospital Quiron Sagrado Corazon: lead

Related Publications (2)

• Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607.

  PMID: 25230375 BACKGROUND

• 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.

  PMID: 23460154 BACKGROUND

Study Officials

• Antonio Artigas, MD

  Hospital Universitari Sagrat Cor, Grupo Quironsalud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Morales, MD

CONTACT

+ 34 648493973; [email protected]

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 31, 2019
• Study Start: February 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access request will be reviewed by an External Independent Review Panel. Requestors will be required to signed a Data Access.