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Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome.

ABSTRACT: Coronavirus disease 2019 (COVID-19)-associated acute respiratory distress syndrome (ARDS) is associated with high mortality. Lung-protective ventilation is the current standard of care in patients with ARDS, but it might lead to hypercapnia, which is independently associated with worse outcomes. Extracorporeal carbon dioxide removal (ECCO₂R) has been proposed as an adjuvant therapy to avoid progression of clinical severity and limit further ventilator-induced lung injury, but its use in COVID-19 has not been described yet. Acute kidney injury requiring renal replacement therapy (RRT) is common among critically ill COVID-19 patients. In centers with available dialysis, low-flow ECCO₂R (<500 mL/min) using RRT platforms could be carried out by dialysis specialists and might be an option to efficiently allocate resources during the COVID-19 pandemic for patients with hypercapnia as the main indication. Here, we report the feasibility, safety, and efficacy of ECCO₂R using an RRT platform to provide either standalone ECCO₂R or ECCO₂R combined with RRT in four hypercapnic patients with moderate ARDS. A randomized clinical trial is required to assess the overall benefit and harm. Clinical Trial Registration: ClinicalTrials.gov. Unique identifier: NCT04351906.

SUBMITTER: Husain-Syed F

PROVIDER: S-EPMC7693445 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome.

Husain-Syed Faeq F Birk Horst-Walter HW Wilhelm Jochen J Ronco Claudio C Ranieri V Marco VM Karle Bianka B Kuhnert Stefan S Tello Khodr K Hecker Matthias M Morty Rory E RE Herold Susanne S Kehl Oliver O Walmrath Hans-Dieter HD Seeger Werner W Vadász István I

Frontiers in medicine 20201112

Coronavirus disease 2019 (COVID-19)-associated acute respiratory distress syndrome (ARDS) is associated with high mortality. Lung-protective ventilation is the current standard of care in patients with ARDS, but it might lead to hypercapnia, which is independently associated with worse outcomes. Extracorporeal carbon dioxide removal (ECCO<sub>2</sub>R) has been proposed as an adjuvant therapy to avoid progression of clinical severity and limit further ventilator-induced lung injury, but its use ...[more]

PMID: 33304914

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Project description:BackgroundPatients presenting with acute hypercapnic respiratory failure due to exacerbations of chronic obstructive pulmonary disease (AECOPD) are typically managed with non-invasive ventilation (NIV). The impact of low-flow extracorporeal carbon dioxide removal (ECCO2R) on outcome in these patients has not been explored in randomised trials.MethodsOpen-label randomised trial comparing NIV (NIV arm) with ECCO2R (ECCO2R arm) in patients with AECOPD at high risk of NIV failure (pH < 7.30 after ≥ 1 h of NIV). The primary endpoint was time to cessation of NIV. Secondary outcomes included device tolerance and complications, changes in arterial blood gases, hospital survival.ResultsEighteen patients (median age 67.5, IQR (61.5-71) years; median GOLD stage 3 were enrolled (nine in each arm). Time to NIV discontinuation was shorter with ECCO2R (7:00 (6:18-8:30) vs 24:30 (18:15-49:45) h, p = 0.004). Arterial pH was higher with ECCO2R at 4 h post-randomisation (7.35 (7.31-7.37) vs 7.25 (7.21-7.26), p < 0.001). Partial pressure of arterial CO2 (PaCO2) was significantly lower with ECCO2R at 4 h (6.8 (6.2-7.15) vs 8.3 (7.74-9.3) kPa; p = 0.024). Dyspnoea and comfort both rapidly improved with commencement of ECCO2R. There were no severe or life-threatening complications in the study population. There were no episodes of major bleeding or red blood cell transfusion in either group. ICU and hospital length of stay were longer with ECCO2R, and there was no difference in 90-day mortality or functional outcomes at follow-up.InterpretationThere is evidence of benefit associated with ECCO2R with time to improvement in respiratory acidosis, in respiratory physiology and an immediate improvement in patient comfort and dyspnoea with commencement of ECCO2R. In addition, there was minimal clinically significant adverse events associated with ECCO2R use in patients with AECOPD at risk of failing or not tolerating NIV. However, the ICU and hospital lengths of stay were longer in the ECCO2R for similar outcomes. Trial registration The trial is prospectively registered on ClinicalTrials.gov: NCT02086084. Registered on 13th March 2014, https://clinicaltrials.gov/ct2/show/NCT02086084?cond=ecco2r&draw=2&rank=8.

Project description:Mechanical ventilation (MV) represents a lifesaving treatment for patients with respiratory failure, but it could be harmful through the development of ventilator-induced lung injury (VILI). In patients with acute respiratory distress syndrome (ARDS), protective MV strategies with low tidal volume to minimize VILI have been demonstrated to reduce lung injury and mortality. However, they can be limited by the emergence of uncontrolled hypercapnia. Similarly, in COPD patients, noninvasive MV failure often is associated with a progressive rise in arterial CO2 and need for endotracheal intubation, with higher risk of hospital mortality. Minimally invasive extracorporeal CO2 removal systems (ECCO2R) theoretically can remove the entire amount of the CO2 produced in the body per minute. In ARDS patients, ECCO2R may further reduce the risk of VILI ensuring ultraprotective MV and avoiding hypercapnia. In patients with exacerbation of COPD, ECCO2R may help to avoid intubation or facilitate weaning from invasive MV. In intensive care unit, concomitant renal and respiratory failure with MV is one of the strongest risk factors for hospital mortality. Combining ECCO2R and renal replacement therapy may support respiratory and renal functions and limit the side effects of MV. However, the need for systemic anticoagulation and the related risk of bleeding still represent a concern for a wider application of ECCO2R devices. In conclusion, ECCO2R is an effective support therapy to MV to limit its invasiveness and side effects, but its efficacy and safety must be proven in well-designed clinical trials. Objectives This chapter will:1 Explain the physiology of CO2 removal during extracorporeal support.2 Describe potential clinical applications of extracorporeal CO2 removal systems (ECCO2R) support therapy in patients with acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disease (COPD) as well as in those with acute kidney injury requiring renal replacement therapy.

Project description:BACKGROUND:Extracorporeal carbon-dioxide removal (ECCO2R) might allow ultraprotective mechanical ventilation with lower tidal volume (VT) (<?6 ml/kg predicted body weight), plateau pressure (Pplat) (<?30 cmH2O), and driving pressure to limit ventilator-induced lung injury. This study was undertaken to assess the feasibility and safety of ECCO2R managed with a renal replacement therapy (RRT) platform to enable very low tidal volume ventilation of patients with mild-to-moderate acute respiratory distress syndrome (ARDS). METHODS:Twenty patients with mild (n?=?8) or moderate (n?=?12) ARDS were included. VT was gradually lowered from 6 to 5, 4.5, and 4 ml/kg, and PEEP adjusted to reach 23???Pplat???25 cmH2O. Standalone ECCO2R (no hemofilter associated with the RRT platform) was initiated when arterial PaCO2 increased by >?20% from its initial value. Ventilation parameters (VT, respiratory rate, PEEP), respiratory system compliance, Pplat and driving pressure, arterial blood gases, and ECCO2R-system operational characteristics were collected during at least 24 h of very low tidal volume ventilation. Complications, day-28 mortality, need for adjuvant therapies, and data on weaning off ECCO2R and mechanical ventilation were also recorded. RESULTS:While VT was reduced from 6 to 4 ml/kg and Pplat kept <?25 cmH2O, PEEP was significantly increased from 13.4?±?3.6 cmH2O at baseline to 15.0?±?3.4 cmH2O, and the driving pressure was significantly reduced from 13.0?±?4.8 to 7.9?±?3.2 cmH2O (both p?<?0.05). The PaO2/FiO2 ratio and respiratory-system compliance were not modified after VT reduction. Mild respiratory acidosis occurred, with mean PaCO2 increasing from 43?±?8 to 53?±?9 mmHg and mean pH decreasing from 7.39?±?0.1 to 7.32?±?0.10 from baseline to 4 ml/kg VT, while the respiratory rate was not altered. Mean extracorporeal blood flow, sweep-gas flow, and CO2 removal were 421?±?40 ml/min, 10?±?0.3 L/min, and 51?±?26 ml/min, respectively. Mean treatment duration was 31?±?22 h. Day-28 mortality was 15%. CONCLUSIONS:A low-flow ECCO2R device managed with an RRT platform easily and safely enabled very low tidal volume ventilation with moderate increase in PaCO2 in patients with mild-to-moderate ARDS. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02606240. Registered on 17 November 2015.

Project description:Mechanical ventilation with a tidal volume (VT) of 6 mL/kg/predicted body weight (PBW), to maintain plateau pressure (Pplat) lower than 30 cmH2O, does not completely avoid the risk of ventilator induced lung injury (VILI). The aim of this study was to evaluate safety and feasibility of a ventilation strategy consisting of very low VT combined with extracorporeal carbon dioxide removal (ECCO2R).In fifteen patients with moderate ARDS, VT was reduced from baseline to 4 mL/kg PBW while PEEP was increased to target a plateau pressure--(Pplat) between 23 and 25 cmH2O. Low-flow ECCO2R was initiated when respiratory acidosis developed (pH < 7.25, PaCO2 > 60 mmHg). Ventilation parameters (VT, respiratory rate, PEEP), respiratory compliance (CRS), driving pressure (DeltaP = VT/CRS), arterial blood gases, and ECCO2R system operational characteristics were collected during the period of ultra-protective ventilation. Patients were weaned from ECCO2R when PaO2/FiO2 was higher than 200 and could tolerate conventional ventilation settings. Complications, mortality at day 28, need for prone positioning and extracorporeal membrane oxygenation, and data on weaning from both MV and ECCO2R were also collected.During the 2 h run in phase, VT reduction from baseline (6.2 mL/kg PBW) to approximately 4 mL/kg PBW caused respiratory acidosis (pH < 7.25) in all fifteen patients. At steady state, ECCO2R with an average blood flow of 435 mL/min and sweep gas flow of 10 L/min was effective at correcting pH and PaCO2 to within 10 % of baseline values. PEEP values tended to increase at VT of 4 mL/kg from 12.2 to 14.5 cmH2O, but this change was not statistically significant. Driving pressure was significantly reduced during the first two days compared to baseline (from 13.9 to 11.6 cmH2O; p < 0.05) and there were no significant differences in the values of respiratory system compliance. Rescue therapies for life threatening hypoxemia such as prone position and ECMO were necessary in four and two patients, respectively. Only two study-related adverse events were observed (intravascular hemolysis and femoral catheter kinking).The low-flow ECCO2R system safely facilitates a low volume, low pressure ultra-protective mechanical ventilation strategy in patients with moderate ARDS.

Project description:Background/aimTreatment of severe hypercapnic respiratory failure (HRF) has some challenges in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS), especially when lung protective ventilation (LPV) strategies are required. Extracorporeal CO2 removal (ECCO2R) therapy is an emerging option to manage hypercapnia while allowing LPV in these cases. However, further data on ECCO2R use is still needed to make clear recommendations.Materials and methodsThis study was conducted on patients admitted to intensive care unit (ICU) between January 1st, 2016 to December 31st, 2019. The medical records were retrospectively scanned in institutional software database. Patients who received invasive mechanic ventilation (iMV) support due to severe HRF related to COPD or ARDS were included in the analyses. Patients were grouped according to treatment approaches as that ECCO2R therapy in addition to conventional treatments and conventional treatments alone (controls). Groups were compared for 28-day survival, iMV duration, and length of stay (LOS).ResultsECCO2R therapy was noted in 75 of the cases among included 395 patients (COPD n = 256, ARDS n = 139) out of scanned 1715 medical records. The survival rate of ECCO2R patients was 68% and significantly higher than 58% survival rate of controls (p = 0.025), with relative risk reduction (RRR) = 0.16, absolute risk reduction (ARR)= 0.10, number need to treat (NNT) = 10, and odds ratio (OR) = 1.5. In addition, iMV duration (12.8 ± 2.6 vs. 17.1 ± 4.9 days, p = 0.007) and LOS (16.9 ± 4.1 vs. 18.9 ± 5.5 days, p = 0.032) were significantly shorter than controls. Repeated measure analyses showed that LPV settings were successfully provided by 72 h of ECCO2R therapy. Subgroup analyses according to diagnoses of COPD and ARDS also favored ECCO2R.ConclusionECCO2R therapy significantly improved survival, iMV duration and LOS in patients with severe HRF due to COPD or ARDS, and successfully provided LPV approaches. Further studies are needed to assess promising benefits of ECCO2R therapy.

Project description:BackgroundChronic obstructive pulmonary disease (COPD) is a common cause of chronic respiratory failure and its course is punctuated by a series of acute exacerbations which commonly lead to hospital admission. Exacerbations are managed through the application of non-invasive ventilation and, when this fails, tracheal intubation and mechanical ventilation. The need for mechanical ventilation significantly increases the risk of death. An alternative therapy, extracorporeal carbon dioxide removal (ECCO2R), has been shown to be efficacious in removing carbon dioxide from the blood; however, its impact on respiratory physiology and patient outcomes has not been explored.Methods/designA randomised controlled open label trial of patients (12 in each arm) with acute exacerbations of COPD at risk of failing conventional therapy (NIV) randomised to either remaining on NIV or having ECCO2R added to NIV with a primary endpoint of time to cessation of NIV. The change in respiratory physiology following the application of ECCO2R and/or NIV will be measured using electrical impedance tomography, oesophageal pressure and parasternal electromyography. Additional outcomes, including patient tolerance, outcomes, need for readmission, changes in blood gases and biochemistry and procedural complications, will be measured. Physiological changes will be compared within one patient over time and between the two groups. Healthcare costs in the UK system will also be compared between the two groups.DiscussionCOPD is a common disease and exacerbations are a leading cause of hospital admission in the UK and worldwide, with a sizeable mortality. The management of patients with COPD consumes significant hospital and financial resources. This study seeks to understand the feasibility of a novel approach to the management of patients with acute exacerbations of COPD as well as to understand the underlying physiological changes to explain why the approach does or does not assist this patient cohort. Detailed respiratory physiology has not been previously undertaken using this technique and there are no other randomised controlled trials currently in the literature.Trial registrationClinicalTrials.gov, NCT02086084.

Project description:Background:Tidal hyperinflation can still occur with mechanical ventilation using low tidal volume (LVT) (6?mL/kg predicted body weight (PBW)) in acute respiratory distress syndrome (ARDS), despite a well-demonstrated reduction in mortality. Methods:Retrospective chart review from August 2012 to October 2014. Inclusion: Age >18years, PaO2/FiO2<200 with bilateral pulmonary infiltrates, absent heart failure, and ultra-protective mechanical ventilation (UPMV) defined as tidal volume (VT) <6?mL/kg PBW. Exclusion: UPMV use for <24?h. Demographics, admission Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, arterial blood gas, serum bicarbonate, ventilator parameters for pre-, during, and post-UPMV periods including modes, VT, peak inspiratory pressure (PIP), plateau pressure (Pplat), driving pressure, etc. were gathered. We compared lab and ventilator data for pre-, during, and post-UPMV periods. Results:Fifteen patients (male:female?=?7:8, age 42.13?±?11.29 years) satisfied criteria, APACHEII 20.6?±?7.1, mean days in intensive care unit and hospitalization were 18.5?±?8.85 and 20.81?±?9.78 days, 9 (60%) received paralysis and 7 (46.67%) required inotropes. Eleven patients had echocardiogram, 7 (63.64%) demonstrated right ventricular volume or pressure overload. Eleven patients (73.33%) survived. During-UPMV, VT ranged 2-5?mL/kg PBW(3.99?±?0.73), the arterial partial pressure of carbon dioxide (PaCO2) was higher than pre-UPMV values (84.81?±?18.95 cmH2O vs. 69.16?±?33.09 cmH2O), but pH was comparable and none received extracorporeal carbon dioxide removal (ECCO2-R). The positive end-expiratory pressure (14.18?±?7.56 vs. 12.31?±?6.84 cmH2O), PIP (38.21?±?12.89 vs. 32.59?±?9.88), and mean airway pressures (19.98?±?7.61 vs. 17.48?±?6.7?cm H2O) were higher during UPMV, but Pplat and PaO2/FiO2 were comparable during- and pre-UPMV. Driving pressure was observed to be higher in those who died than who survived (24.18?±?12.36 vs. 13.42?±?3.25). Conclusion:UPMV alone may be a safe alternative option for ARDS patients in centers without ECCO2-R.

Dataset Information

Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome.

Publications

Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome.

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