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

NCT03990155 | Unknown

• 1 other identifier: Fondazione IRCCS Ca' Granda
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure With Hypercapnia

Outcome Measures

Primary Outcomes (1)

• 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 1. Respiratory acidosis (pH \<7.35) 2. RR ≥ 30 bpm 3. Development of progressive hypoxemia (PaO2/FiO2 \< 150) 4. Paradoxical breathing

  Through study completion, an average of 2 years

Secondary Outcomes (14)

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

• Variation of respiratory mechanic during ECCO2R+NIV

  Through study completion, an average of 2 years

Study Arms (1)

HFNCOT+ECCO2R

EXPERIMENTAL

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

Procedure: HFNCOT+ECCO2R

Interventions

HFNCOT+ECCO2R PROCEDURE

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.

HFNCOT+ECCO2R

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Policlinico Hospital: lead
• Niguarda Hospital: collaborator
• San Gerardo Hospital: collaborator
• Ospedale San Paolo: collaborator

Study Sites (1)

Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Study Officials

• Giacomo Grasselli, Professor

  Policlinico Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Grasselli, Professor

CONTACT

+ 39 02 55036708; giacomo.grasselli@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

IT (1)