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Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease

Primary Purpose

Respiratory Failure With Hypercapnia

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

HFNCOT+ECCO2R

About this trial

This is an interventional treatment trial for Respiratory Failure With Hypercapnia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted to Emergency or Pulmonology Department, with history of COPD (pulmonary function test available, any Global Obstructive Lung Disease -GOLD- stage), treated with NIV for acute hypercapnic respiratory failure due to AECOPD defined by:

pH <7.35 + PaCO2 >45 mmHg (acute hypercapnic respiratory failure) or pH <7.35 + PaCO2 > 20% of baseline value (acute on chronic hypercapnic respiratory failure)
Acute worsening of respiratory symptoms that results in additional therapy
Respiratory failure not fully explainable with cardiac failure and at high risk for NIV failure, defined by:
No improvement or worsening of respiratory acidosis (pH <7.35 and PaCO2 >45 mmHg) after 2 hours of NIV + one of the following: RR ≥30 bpm; use of accessory respiratory muscle or paradoxical breathing (Combination criteria for NIV failure) or
Glasgow Coma Scale ≤ 11 after 2 hours of NIV (Single criteria for NIV failure) or
Inability to fit mask (facial deformity/intervention/burns) or marked intolerance to interface because of patient's agitation (Single Criteria for NIV failure)

Exclusion Criteria:

Age >80 years old
Contraindications to anticoagulation (any of the following: platelet count <30.000/mm3; activated partial thromboplastin time (aPTT) >1,5; stroke or severe head trauma or intracranial arteriovenous malformation or cerebral aneurysm in the previous 3 months; central nervous system mass lesion; history of congenital bleeding diatheses; gastro-intestinal bleeding in the previous 6 weeks; gastro-esophageal varices)
Cirrhosis
PaO2/FiO2 ≤ 150 mmHg
Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)
Body Mass Index ≥37
Impending respiratory arrest
Catheter access to femoral vein or jugular vein impossible
Patient moribund, decision to limit therapeutic interventions
Opposition to participate obtained from the patient or their legally acceptable representative

Sites / Locations

Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HFNCOT+ECCO2R

Arm Description

Patients on NIV+ECCO2R who have reached at least for 4 consecutive hours, a RR <25 bpm + pH >7.35 + absence of clinical signs of respiratory distress after treatment with NIV+ECCO2R

Outcomes

Primary Outcome Measures

Number of partecipants failing HFNCOT+ECCO2R treatment with need of restoring NIV or need of invasive mechanical ventilation

ECCO2R+HFNCOT failure criteria are defined by at least two of the following after at least 1 hour of treatment Respiratory acidosis (pH <7.35) RR ≥ 30 bpm Development of progressive hypoxemia (PaO2/FiO2 < 150) Paradoxical breathing

Secondary Outcome Measures

Number of partecipants failing NIV+ECCO2R treatment with need of invasive mechanical ventilation

NIV+ECCO2R failure is defined by two of the following occurring for at least 2 hours: No improvement or worsening of respiratory acidosis (pH <7.35) RR ≥30 bpm Development of progressive hypoxemia (PaO2/FiO2 ≤150)

Number of patients treated with ECCO2R reporting one or more side effects due to ECCO2R

Bleeding (any bleeding event requiring the administration of 1 U of packed red cells) Vein perforation at cannula insertion Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias) Pneumothorax Ischemic bowel Acute kidney failure Neurological complications (occurrence, after initiation of ECCO2R, of ischemic/hemorrhagic ictus or clinical seizure or cerebral oedema) Metabolic complications (occurrence, after initiation of ECCO2R of hyperbilirubinemia or glucose≥240 mg/dL) Thromboembolic complications (occurrence, after initiation of ECCO2R, of deep venous thrombosis, pulmonary embolism)

Variation of pulmonary arterial pressure before and after ECCO2R treatment either in association with NIV or HNFCOT

Echocardiographic measurement

Variation of tricuspid annluar plane systolic excursion before and after ECCO2R treatment either in association with NIV or HNFCOT

Echocardiographic measurement

Variation of respiratory mechanic during ECCO2R+NIV

Measurement of Respiratory Rate (breaths per minute)

Variation of dyspnea during ECCO2R+NIV

Measurement of dyspnea through Borg dyspnea scale. (ranging from a minimum of 0 point, indicating no shortness of breath, to a maximum of 10 points, indicating maximum shortness of breath)

Variation of comfort during ECCO2R+NIV

Measurement of comfort through Visual Analogic Scale for comfort, ranging from a minimum of 0 point, indicating no comfort, to a maximun of 10 point, indicating maximum comfort

Variation of respiratory mechanic during ECCO2R+HFNCOT

Measurement of Respiratory Rate (breaths per minute)

Variation of dyspnea during ECCO2R+HFNCOT

Measurement of dyspnea through Borg dyspnea scale, ranging from a minimum of 0 point, indicating no shortness of breath, to a maximum of 10 points, indicating maximum shortness of breath

Variation of comfort during ECCO2R+HFNCOT

Measurement of comfort through Visual Analogic Scale for comfort, ranging from a minimum of 0 point, indicating no comfort, to a maximun of 10 point, indicating maximum comfort

Variation of breathing pattern during ECCO2R+NIV

Measurement of expiratory tidal volume, expressed in mL

Variation of breathing pattern during ECCO2R+NIV

Measurement of minute ventilation, expressed in liters/minute

Variation of acid-base balance during ECCO2R+NIV

emogasanalysis

Variation of acid-base balance during ECCO2R+HFNCOT

emogasanalysis

Full Information

NCT ID

NCT03990155

First Posted

May 27, 2019

Last Updated

June 15, 2019

Sponsor

Policlinico Hospital

Collaborators

Niguarda Hospital, San Gerardo Hospital, Ospedale San Paolo

1. Study Identification

Unique Protocol Identification Number

NCT03990155

Brief Title

Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease

Official Title

Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Extracorporeal Carbon Dioxide Removal Associated With High Flow Nasal Cannula Oxygen Therapy. Pilot Study.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Anticipated)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Policlinico Hospital

Collaborators

Niguarda Hospital, San Gerardo Hospital, Ospedale San Paolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Around 20% of the patients requiring hospitalization for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) develop hypercapnia, which is associated with an increased risk of death. Once Non Invasive Ventilation (NIV) has been initiated, a reduction in Respiratory Rate (RR) and improvement in pH within 4 h predicts NIV success. If pH <7.25 and RR >35 breath per minutes persist, NIV failure is likely. Worsening acidosis, after initial improvement with NIV, is also associated with a worse prognosis. In addition, it has been shown that delaying intubation in patients at high risk for NIV failure has a negative impact on patient survival. Hence, assessing the risk of NIV failure is extremely important. NIV has some limitations: a) intolerance, discomfort and claustrophobia requiring frequent interruptions; b) poor patient-ventilator synchrony, especially in presence of air leaks or high ventilatory requirements. Since removing carbon dioxide by means of an artificial lung reduces the minute ventilation required to maintain an acceptable arterial partial pressure of carbon dioxide (PaCO2), the investigators hypothesize that applying Extra-Corporeal CO2 Removal (ECCO2R) in high-risk AECOPD patients may reduce the incidence of NIV failure and improve patient-ventilator interaction. After the beginning of ECCO2R, NIV could be gradually replaced by High Flow Nasal Cannula Oxygen Therapy (HFNCOT), potentially reducing the risk of ventilator induced lung injury, improving patient's comfort and probably allowing the adoption of a more physiologically "noisy" pattern of spontaneous breathing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure With Hypercapnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HFNCOT+ECCO2R

Arm Type

Experimental

Arm Description

Patients on NIV+ECCO2R who have reached at least for 4 consecutive hours, a RR <25 bpm + pH >7.35 + absence of clinical signs of respiratory distress after treatment with NIV+ECCO2R

Intervention Type

Procedure

Intervention Name(s)

HFNCOT+ECCO2R

Intervention Description

NIV will be discontinued, the ECCO2R setting will be unchanged (both sweep gas flow and blood flow through the artificial lung) and HFNCOT will be started, titrating the fraction of inspired Oxygen (FiO2) to obtain an oxygen saturation at periphery (SpO2) 88-92%; HFNCOT start temperature will be 31°C, the initial flow rate will be 60 L/min.

Primary Outcome Measure Information:

Title

Number of partecipants failing HFNCOT+ECCO2R treatment with need of restoring NIV or need of invasive mechanical ventilation

Description

Time Frame