Trial Radar AI | ||
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Clinical Trial NCT05546606 (CORAIL) for COPD Acute Exacerbation is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Assistance Publique - Hôpitaux de ParisCO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases (CORAIL)
Selection period: before randomisation, demographics, medical and surgical history, clinical examination (including physical examination, respiration rate, encephalopathy score, sedation score, pain assessment, Simplified Acute Physiology Score 2, central body temperature, systolic and diastolic blood pressures, heart rate), blood sampling, electrocardiogram and ventilator parameters will be recorded.
Follow-up period: ECCO2R will start as soon as possible after randomisation in patients allocated to the strengthen standard of care group. All patients will be evaluated 12 + 2 hours after randomisation, followed by a daily visit with the collection of the following data if applicable: clinical examination, ECCO2R parameters, ventilator parameters, concomitant medications (including sedative drugs), occurrence of adverse events, date, time and criteria if endotracheal intubation (stratum 1). Arterial blood gases, hematology and serum biochemistry parameters will be assayed daily.
End of Research period: all patients will be evaluated at day 60 (+ 7 days), Day 90 (+ 7 days), Day 180 (+ 7 days) and 1 year (+ 7 days) at least by phone contact, with collection of: vital status, functional status (Severely Disabled or not, Katz Index of Independence in Activities of Daily Living), date of ICU discharge (if > Day 28), date of hospital discharge, occurrences of ICU re-admissions, of adverse events, type and length of mechanical ventilation needed if applicable.
CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases
- CORAIL
- P150913J
- 2022-A01343-40 (Other Identifier) (Agence Nationale de sécurité du médicament et des produits de santé)
- PHRC-15-557 (Other Grant/Funding Number) (French ministry of health)
COPD
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionSingle standard of care COPD patients who require respiratory support for severe acute exacerbation (AE), either with NIV or with IMV. | N/A |
OtherStrengthen standard of care reinforced with ECCO2R COPD patients who require respiratory support for severe acute exacerbations (AE), either with NIV or with IMV reinforced with ECCO2R | ECCO2R ECCO2R therapy using the Xenios platform, CE-marked medical device of the firm Xenios AG (Heilbronn, Germany), including the following components: Xenios console, iLA active iLA Kit IPS and Novaport Twin (18Fr, 22Fr or 24 Fr) cannulas The maximal duration of ECCO2R therapy with one circuit will be of 29 days in agreement with the regulatory approval of the patient kit. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mortality rate | To determine the best strategy between strengthen standard of care reinforced with ECCO2R, versus single standard of care, | Up to 60 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Invasive Ventilator-free days (IVFDs) | To assess the efficacy of ECCO2R, based on the time on IMV | at 28 and 60 days |
Ventilator-free days (VFDs), including both IVFDs and non-invasive ventilator-free days (NIV-VFDs) | To assess the efficacy of ECCO2R, based on the time on IMV | at 28 and 60 days |
28 day, 90 day, 180 day and 1 year all-cause mortality rate | To assess the efficacy of ECCO2R, based on the all-cause mortality | Up to 1 year |
Length of ECCO2R therapy | To assess the efficacy of ECCO2R, based on ECCO2R device's performance | Up to 28 days |
Proportion of patients without intubation and IMV (intubation and IMV avoided) | To assess the efficacy of ECCO2R, based on intubation rate | Up to 28 days |
Number of days with active mobilization (outside the bed) | To assess the efficacy of ECCO2R, based on the ability to actively mobilize the patients | Up to 28 days |
Rate of inability to wean from IMV | To assess the safety, based on central venous catheter-related complications | at Day 28 and Day 60 |
Rate of ventilator associated pneumonia | To assess the safety, based on central venous catheter-related complications | at Day 28 and Day 60 |
Rate of central venous catheter infection | To assess the safety, based on ECCO2R-related complications, | Up to 28 days |
Rate of deep venous thrombosis | To assess the safety, based on ECCO2R-related complications, | Up to 28 days |
Rate of vascular injury caused by cannulation | To assess the safety, based on ECCO2R-related complications, | Up to 28 days |
Rate of severe bleeding (any cause) | To assess the safety, based on ECCO2R-related complications, | Up to 28 days |
Rate of severe hemolysis | To assess the safety, based on ECCO2R-related complications, | Up to 28 days |
Rate of heparin-induced thrombocytopenia - type II | To assess the safety, based on ECCO2R-related complications, | Up to 28 days |
Age ≥ 18 years
Known or suspected diagnosis of COPD based on clinical history, pulmonary function test when available, arterial blood gases, physical examination, and chest radiograph
Worsening dyspnea for < 2 weeks
Written informed consent signed by patients or their surrogates, with possibility of an emergency procedure with deferred consent
Patient affiliated to a Social Security System (excluding "AME: aide médicale d'état")
Negative serum or urinary β-hCG for women of child-bearing potential
Very severe AE criteria defined either by:
- Stratum 1: high likelihood of NIV failure defined by PaCO2 > 55 mmHg and pH < 7.25, either at baseline and/or after at least one hour of NIV
- Stratum 2: intubation and IMV since less than 72 hrs, either after NIV failure and/or with pH < 7.30 and PaCO2 > 55 mmHg and PEEPi (end-expiratory occlusion) > 5 cmH2O, while on Assist-Controlled Ventilation with the following parameters: VT: 8 ml/kg, RR: 12/min., applied PEEP: 0 cmH2O
Hemodynamic instability
Known allergy to heparin or to any of the excipients of the specialty used
Contra-indications to heparin listed in the SmPC of the specialty used.
History of type II Heparin-induced thrombocytopenia
Thrombocytopenia (platelets < 100.000/mm3)
Recent major surgery
Haemorrhagic disorders such as:
- Organic lesion likely to bleed
- Bleeding manifestations or tendencies linked to disorders of hemostasis
- Intracerebral hemorrhage
Uncontrolled arrhythmia
Bleeding diathesis
Body Mass Index > 35 kg/m2
PaO2/FiO2 < 180 mmHg
Do not intubate order
Fibrosing idiopathic interstitial pneumonitis (based on the available medical files)
Neuromuscular diseases (based on the available medical files)
Patients with tracheotomy
Patients with severe concomitant chronic systemic disease with a limited probability of survival (< 6 months)
Severely disabled (confinement to bed and inability to wash or dress alone) patients before AE
Pregnant woman
Participation in another interventional study involving human participants up to their ICU discharge, whether the studies include an investigational medical device, or being in the exclusion period at the end of a previous study.
Assistance Publique - Hôpitaux de Paris961 active trials to explore- Ministry of Health, France
- Xenios AG