Low flow extracorporeal CO2 removal in ARDS patients: a prospective short-term crossover pilot study.
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ABSTRACT:
SUBMITTER: Peperstraete H
PROVIDER: S-EPMC5704518 | biostudies-literature | 2017 Nov
REPOSITORIES: biostudies-literature
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Low flow extracorporeal CO<sub>2</sub> removal in ARDS patients: a prospective short-term crossover pilot study.
Peperstraete Harlinde H Eloot Sunny S Depuydt Pieter P De Somer Filip F Roosens Carl C Hoste Eric E
BMC anesthesiology 20171128 1
<h4>Background</h4>Lung protective mechanical ventilation (MV) is the corner stone of therapy for ARDS. However, its use may be limited by respiratory acidosis. This study explored feasibility of, effectiveness and safety of low flow extracorporeal CO<sub>2</sub> removal (ECCO<sub>2</sub>R).<h4>Methods</h4>This was a prospective pilot study, using the Abylcap® (Bellco) ECCO<sub>2</sub>R, with crossover off-on-off design (2-h blocks) under stable MV settings, and follow up till end of ECCO<sub>2< ...[more]
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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.
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Project description:BackgroundAcute respiratory distress syndrome is characterized by damage to the lung caused by various insults, including ventilation itself, and tidal hyperinflation can lead to ventilator induced lung injury (VILI). We investigated the effects of a low tidal volume (V(T)) strategy (V(T) ≈ 3 ml/kg/predicted body weight [PBW]) using pumpless extracorporeal lung assist in established ARDS.MethodsSeventy-nine patients were enrolled after a 'stabilization period' (24 h with optimized therapy and high PEEP). They were randomly assigned to receive a low V(T) ventilation (≈3 ml/kg) combined with extracorporeal CO2 elimination, or to a ARDSNet strategy (≈6 ml/kg) without the extracorporeal device. The primary outcome was the 28-days and 60-days ventilator-free days (VFD). Secondary outcome parameters were respiratory mechanics, gas exchange, analgesic/sedation use, complications and hospital mortality.ResultsVentilation with very low V(T)'s was easy to implement with extracorporeal CO2-removal. VFD's within 60 days were not different between the study group (33.2 ± 20) and the control group (29.2 ± 21, p = 0.469), but in more hypoxemic patients (PaO2/FIO2 ≤150) a post hoc analysis demonstrated significant improved VFD-60 in study patients (40.9 ± 12.8) compared to control (28.2 ± 16.4, p = 0.033). The mortality rate was low (16.5%) and did not differ between groups.ConclusionsThe use of very low V(T) combined with extracorporeal CO2 removal has the potential to further reduce VILI compared with a 'normal' lung protective management. Whether this strategy will improve survival in ARDS patients remains to be determined (Clinical trials NCT 00538928).
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Project description:Background:Extracorporeal carbon dioxide removal (ECCO2R) is a promising technique for the management of acute respiratory failure, but with a limited level of evidence to support its use outside clinical trials and/or data collection initiatives. We report a collaborative initiative in a large metropolis. Methods:To assess on a structural basis the rate of utilization as well as efficacy and safety parameters of 2 ECCO2R devices in 10 intensive care units (ICU) during a 2-year period. Results:Seventy patients were recruited in 10 voluntary and specifically trained centers. The median utilization rate was 0.19 patient/month/center (min 0.04; max 1.20). ECCO2R was started under invasive mechanical ventilation (IMV) in 59 patients and non-invasive ventilation in 11 patients. The Hemolung Respiratory Assist System (Alung) was used in 53 patients and the iLA Activve iLA kit (Xenios Novalung) in 17 patients. Main indications were ultraprotective ventilation for ARDS patients (n?=?24), shortening the duration of IMV in COPD patients (n?=?21), preventing intubation in COPD patients (n?=?9), and controlling hypercapnia and dynamic hyperinflation in mechanically ventilated patients with severe acute asthma (n?=?6). A reduction in median V T was observed in ARDS patients from 5.9 to 4.1?ml/kg (p <0.001). A reduction in PaCO2 values was observed in AE-COPD patients from 67.5 to 51?mmHg (p<?0.001). Median duration of ECCO2R was 5?days (IQR 3-8). Reasons for ECCO2R discontinuation were improvement (n?=?33), ECCO2R-related complications (n?=?18), limitation of life-sustaining therapies or measures decision (n?=?10), and death (n?=?9). Main adverse events were hemolysis (n?=?21), bleeding (n?=?17), and lung membrane clotting (n?=?11), with different profiles between the devices. Thirty-five deaths occurred during the ICU stay, 3 of which being ECCO2R-related. Conclusions:Based on a registry, we report a low rate of ECCO2R device utilization, mainly in severe COPD and ARDS patients. Physiological efficacy was confirmed in these two populations. We confirmed safety concerns such as hemolysis, bleeding, and thrombosis, with different profiles between the devices. Such results could help to design future studies aiming to enhance safety, to demonstrate a still-lacking strong clinical benefit of ECCO2R, and to guide the choice between different devices. Trial registration:ClinicalTrials.gov: Identifier: NCT02965079 retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02965079.
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Project description:Ultra-protective lung ventilation in acute respiratory distress syndrome or early weaning and/or avoidance of mechanical ventilation in decompensated chronic obstructive pulmonary disease may be facilitated by the use of extracorporeal CO2 removal (ECCO2R). We tested the CO2 removal performance of a new ECCO2R (CO2RESET) device in an experimental animal model. Three healthy pigs were mechanically ventilated and connected to the CO2RESET device (surface area = 1.8 m2, EUROSETS S.r.l., Medolla, Italy). Respiratory settings were adjusted to induce respiratory acidosis with the adjunct of an external source of pure CO2 (target pre membrane lung venous PCO2 (PpreCO2): 80-120 mmHg). The amount of CO2 removed (VCO2, mL/min) by the membrane lung was assessed directly by the ECCO2R device. Before the initiation of ECCO2R, the median PpreCO2 was 102.50 (95.30-118.20) mmHg. Using fixed incremental steps of the sweep gas flow and maintaining a fixed blood flow of 600 mL/min, VCO2 progressively increased from 0 mL/min (gas flow of 0 mL/min) to 170.00 (160.00-200.00) mL/min at a gas flow of 10 L/min. In particular, a high increase of VCO2 was observed increasing the gas flow from 0 to 2 L/min, then, VCO2 tended to progressively achieve a steady-state for higher gas flows. No animal or pump complications were observed. Medium-flow ECCO2R devices with a blood flow of 600 mL/min and a high surface membrane lung (1.8 m2) provided a high VCO2 using moderate sweep gas flows (i.e., >2 L/min) in an experimental swine models with healthy lungs.
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Project description:BACKGROUND:There is increasing evidence demonstrating the value of partial extracorporeal CO2 removal (ECCO2R) for the treatment of hypercapnia in patients with acute exacerbations of chronic obstructive pulmonary disease and acute respiratory distress syndrome. Mechanical ventilation has traditionally been used to treat hypercapnia in these patients, however, it has been well-established that aggressive ventilator settings can lead to ventilator-induced lung injury. ECCO2R removes CO2 independently of the lungs and has been used to permit lung protective ventilation to prevent ventilator-induced lung injury, prevent intubation, and aid in ventilator weaning. The Low-Flow Pittsburgh Ambulatory Lung (LF-PAL) is a low-flow ECCO2R device that integrates the fiber bundle (0.65 m2) and centrifugal pump into a compact unit to permit patient ambulation. METHODS:A blood analog was used to evaluate the performance of the pump at various impeller rotation rates. In vitro CO2 removal tested under normocapnic conditions and 6-h hemolysis testing were completed using bovine blood. Computational fluid dynamics and a mass-transfer model were also used to evaluate the performance of the LF-PAL. RESULTS:The integrated pump was able to generate flows up to 700 mL/min against the Hemolung 15.5 Fr dual lumen catheter. The maximum vCO2 of 105 mL/min was achieved at a blood flow rate of 700 mL/min. The therapeutic index of hemolysis was 0.080 g/(100 min). The normalized index of hemolysis was 0.158 g/(100 L). CONCLUSIONS:The LF-PAL met pumping, CO2 removal, and hemolysis design targets and has the potential to enable ambulation while on ECCO2R.
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Project description:BACKGROUND:Lung-protective strategies are the cornerstone of mechanical ventilation in critically ill patients with both ARDS and other disorders. Extracorporeal CO2 removal (ECCO2R) may enhance lung protection by allowing even further reductions in tidal volumes and is effective in low-flow settings commonly used for renal replacement therapy. In this study, we describe for the first time the effects of a labeled and certified system combining ECCO2R and renal replacement therapy on pulmonary stress and strain in hypercapnic patients with renal failure. METHODS:Twenty patients were treated with the combined system which incorporates a membrane lung (0.32 m2) in a conventional renal replacement circuit. After changes in blood gases under ECCO2R were recorded, baseline hypercapnia was reestablished and the impact on ventilation parameters such as tidal volume and driving pressure was recorded. RESULTS:The system delivered ECCO2R at rate of 43.4?±?14.1 ml/min, PaCO2 decreased from 68.3?±?11.8 to 61.8?±?11.5 mmHg (p?<?0.05) and pH increased from 7.18?±?0.09 to 7.22?±?0.08 (p?<?0.05). There was a significant reduction in ventilation requirements with a decrease in tidal volume from 6.2?±?0.9 to 5.4?±?1.1 ml/kg PBW (p?<?0.05) corresponding to a decrease in plateau pressure from 30.6?±?4.6 to 27.7?±?4.1 cmH2O (p?<?0.05) and a decrease in driving pressure from 18.3?±?4.3 to 15.6?±?3.9 cmH2O (p?<?0.05), indicating reduced pulmonary stress and strain. No complications related to the procedure were observed. CONCLUSIONS:The investigated low-flow ECCO2R and renal replacement system can ameliorate respiratory acidosis and decrease ventilation requirements in hypercapnic patients with concomitant renal failure. Trial registration NCT02590575, registered 10/23/2015.
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Project description:IntroductionWhile non-invasive ventilation aimed at avoiding intubation has become the modality of choice to treat mild to moderate acute respiratory acidosis, many severely acidotic patients (pH <7.20) still need intubation. Extracorporeal veno-venous CO2 removal (ECCO2R) could prove to be an alternative. The present animal study tested in a systematic fashion technical requirements for successful ECCO2R in terms of cannula size, blood and sweep gas flow.MethodsECCO2R with a 0.98 m(2) surface oxygenator was performed in six acidotic (pH <7.20) pigs using either a 14.5 French (Fr) or a 19Fr catheter, with sweep gas flow rates of 8 and 16 L/minute, respectively. During each experiment the blood flow was incrementally increased to a maximum of 400 mL/minute (14.5Fr catheter) and 1000 mL/minute (19Fr catheter).ResultsAmelioration of severe respiratory acidosis was only feasible when blood flow rates of 750 to 1000 mL/minute (19Fr catheter) were used. Maximal CO2-elimination was 146.1 ± 22.6 mL/minute, while pH increased from 7.13 ± 0.08 to 7.41 ± 0.07 (blood flow of 1000 mL/minute; sweep gas flow 16 L/minute). Accordingly, a sweep gas flow of 8 L/minute resulted in a maximal CO2-elimination rate of 138.0 ± 16.9 mL/minute. The 14.5Fr catheter allowed a maximum CO2 elimination rate of 77.9 mL/minute, which did not result in the normalization of pH.ConclusionsVeno-venous ECCO2R may serve as a treatment option for severe respiratory acidosis. In this porcine model, ECCO2R was most effective when using blood flow rates ranging between 750 and 1000 mL/minute, while an increase in sweep gas flow from 8 to 16 L/minute had less impact on ECCO2R in this setting.
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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.
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