Respiratory Failure With HypercapniaNCT03990155
Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease
A study testing HFNCOT+ECCO2R in people with Respiratory Failure With Hypercapnia, run by Policlinico Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure With Hypercapnia
- What is being tested?
- HFNCOT+ECCO2R
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore Policlinico
Milan, 20122
Giacomo Grasselli, Prof, 0255033258, giacomo.grasselli@unimi.it
About this study
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.
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
- Being tested
- HFNCOT+ECCO2R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCOT+ECCO2RProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: HFNCOT+ECCO2R |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 years
Secondary outcomes (14)
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)
Measured: Through study completion, an average of 2 years
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)
Measured: 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
Echocardiographic measurement
Measured: 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
Echocardiographic measurement
Measured: Through study completion, an average of 2 years
Variation of respiratory mechanic during ECCO2R+NIV
Measurement of Respiratory Rate (breaths per minute)
Measured: Through study completion, an average of 2 years
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)
Measured: Through study completion, an average of 2 years
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
Measured: Through study completion, an average of 2 years
Variation of respiratory mechanic during ECCO2R+HFNCOT
Measurement of Respiratory Rate (breaths per minute)
Measured: Through study completion, an average of 2 years
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
Measured: Through study completion, an average of 2 years
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
Measured: Through study completion, an average of 2 years
Variation of breathing pattern during ECCO2R+NIV
Measurement of expiratory tidal volume, expressed in mL
Measured: Through study completion, an average of 2 years
Variation of breathing pattern during ECCO2R+NIV
Measurement of minute ventilation, expressed in liters/minute
Measured: Through study completion, an average of 2 years
Variation of acid-base balance during ECCO2R+NIV
emogasanalysis
Measured: Through study completion, an average of 2 years
Variation of acid-base balance during ECCO2R+HFNCOT
emogasanalysis
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure With HypercapniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Niguarda Hospital, San Gerardo Hospital, Ospedale San Paolo
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
- Investigators
- Giacomo Grasselli, Professor, Principal investigator, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990155
- Sponsor's protocol ID
- Fondazione IRCCS Ca' Granda
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03990155
- Acronym / sponsor ID
- Fondazione IRCCS Ca' Granda
- Conditions
- Respiratory Failure With Hypercapnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Collaborators
- Niguarda Hospital, San Gerardo Hospital, Ospedale San Paolo
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNCOT+ECCO2R | Experimental | Procedure: HFNCOT+ECCO2RPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNCOT+ECCO2RNIV 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. | Procedure or surgery | HFNCOT+ECCO2R |
Primary outcome
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
14 secondary outcomes
Number of partecipants failing NIV+ECCO2R treatment with need of invasive mechanical ventilation
Time frame: 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
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
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
Variation of respiratory mechanic during ECCO2R+NIV
Time frame: Through study completion, an average of 2 years
Variation of dyspnea during ECCO2R+NIV
Time frame: Through study completion, an average of 2 years
Variation of comfort during ECCO2R+NIV
Time frame: 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
Variation of dyspnea during ECCO2R+HFNCOT
Time frame: Through study completion, an average of 2 years
Variation of comfort during ECCO2R+HFNCOT
Time frame: 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
Variation of breathing pattern during ECCO2R+NIV
Time frame: 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
Variation of acid-base balance during ECCO2R+HFNCOT
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Grasselli, Professor principal investigator
Policlinico Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNCOT+ECCO2R in people with Respiratory Failure With Hypercapnia, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Grasselli, Professor (+ 39 02 55036708, giacomo.grasselli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.