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

June 15, 2019 updated by: Giacomo Grasselli, Policlinico Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: HFNCOT+ECCO2R
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of partecipants failing HFNCOT+ECCO2R treatment with need of restoring NIV or need of invasive mechanical ventilation
Time Frame: Through study completion, an average of 2 years

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of partecipants failing NIV+ECCO2R treatment with need of invasive mechanical ventilation
Time Frame: Through study completion, an average of 2 years

NIV+ECCO2R failure is defined by two of the following occurring for at least 2 hours:

  1. No improvement or worsening of respiratory acidosis (pH <7.35)
  2. RR ≥30 bpm
  3. Development of progressive hypoxemia (PaO2/FiO2 ≤150)
Through study completion, an average of 2 years
Number of patients treated with ECCO2R reporting one or more side effects due to ECCO2R
Time Frame: Through study completion, an average of 2 years
  1. Bleeding (any bleeding event requiring the administration of 1 U of packed red cells)
  2. Vein perforation at cannula insertion
  3. 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)
  4. Pneumothorax
  5. Ischemic bowel
  6. Acute kidney failure
  7. Neurological complications (occurrence, after initiation of ECCO2R, of ischemic/hemorrhagic ictus or clinical seizure or cerebral oedema)
  8. Metabolic complications (occurrence, after initiation of ECCO2R of hyperbilirubinemia or glucose≥240 mg/dL)
  9. Thromboembolic complications (occurrence, after initiation of ECCO2R, of deep venous thrombosis, pulmonary embolism)
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
Time Frame: Through study completion, an average of 2 years
Echocardiographic measurement
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
Time Frame: Through study completion, an average of 2 years
Echocardiographic measurement
Through study completion, an average of 2 years
Variation of respiratory mechanic during ECCO2R+NIV
Time Frame: Through study completion, an average of 2 years
Measurement of Respiratory Rate (breaths per minute)
Through study completion, an average of 2 years
Variation of dyspnea during ECCO2R+NIV
Time Frame: Through study completion, an average of 2 years
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)
Through study completion, an average of 2 years
Variation of comfort during ECCO2R+NIV
Time Frame: Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
Variation of respiratory mechanic during ECCO2R+HFNCOT
Time Frame: Through study completion, an average of 2 years
Measurement of Respiratory Rate (breaths per minute)
Through study completion, an average of 2 years
Variation of dyspnea during ECCO2R+HFNCOT
Time Frame: Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
Variation of comfort during ECCO2R+HFNCOT
Time Frame: Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
Variation of breathing pattern during ECCO2R+NIV
Time Frame: Through study completion, an average of 2 years
Measurement of expiratory tidal volume, expressed in mL
Through study completion, an average of 2 years
Variation of breathing pattern during ECCO2R+NIV
Time Frame: Through study completion, an average of 2 years
Measurement of minute ventilation, expressed in liters/minute
Through study completion, an average of 2 years
Variation of acid-base balance during ECCO2R+NIV
Time Frame: Through study completion, an average of 2 years
emogasanalysis
Through study completion, an average of 2 years
Variation of acid-base balance during ECCO2R+HFNCOT
Time Frame: Through study completion, an average of 2 years
emogasanalysis
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Policlinico Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Niguarda Hospital
San Gerardo Hospital
Ospedale San Paolo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giacomo Grasselli, Professor, Policlinico Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fondazione IRCCS Ca' Granda

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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