Interventional procedure overview of extracorporeal carbon dioxide removal for acute respiratory failure
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Evidence summary
Population and studies description
This overview is based on 2,261 people from 2 systematic reviews and meta-‑analyses, 3 RCTs, a long-term follow-up analysis of 1 of the RCTs, 2 case series, and a secondary analysis of 1 of the case series. Of these 2,261 people, 1,520 people had the procedure. Some RCTs analysed other included studies in this overview, and this has been factored into the patient count. This overview includes a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 9 studies as the key evidence in table 2 and table 3, and lists 45 other relevant studies in table 5.
The included studies were done in the UK, Germany, Canada, and across Europe. The systematic reviews and meta-analyses were global in scope, but one was done in the UK, and one was done in China.
The systematic review and meta-analysis by Millar et al. (2022) was done in the UK. This was an analysis of 3 RCTs and 18 observational studies to assess the efficacy and safety of ECCO2R versus standard care in people with AHRF. The primary outcome was 30-day mortality.
The systematic review and meta-analysis by Yu et al. (2021) was done in China. This was an analysis of 25 studies to evaluate outcomes in people supported on avECCO2R compared with vvECCO2R for any indication.
The RCT of 412 people by McNamee et al. (2021) was done in the UK. This study is known as the REST trial. The study aimed to determine if ECCO2R could allow lower tidal volume MV in people with AHRF. The primary outcome was 90-day mortality. This study aimed to recruit 1,120 people but was stopped early because of futility. The follow-up analysis by Boyle et al. (2022) reported on 2‑year outcomes from this study.
The RCT of 79 people by Bein et al. (2013) was done in Germany. This study aimed to determine the effects of low tidal volume ventilation allowed by ECCO2R in severe ARDS. The primary outcomes were the VFDs up until day 28 and day 60. Because of issues in recruiting eligible people in the enrolment period, the study did not reach the prespecified recruitment of 120 people.
The RCT of 18 people by Barrett et al. (2022) was done in the UK. This study aimed to determine the impact of ECCO2R in people with acute hypercapnic respiratory failure because of acute exacerbation of COPD. The primary outcome in this study was time to cessation of NIV.
The prospective case series of 95 people by Combes et al. (2019a) recruited people from Canada and across Europe. This study assessed the feasibility and safety of ECCO2R to allow low tidal volume ventilation in people with moderate ARDS. The primary outcome was the number of people who achieved a tidal volume of 4 ml/kg with less than a resulting 20% rise in PaCO2. The secondary analysis of this study by Combes et al. (2019b) aimed to determine if the efficacy and safety of ECCO2R in facilitating low tidal volume ventilation varied between low CO2 extraction capacity devices and high CO2 extraction capacity devices.
The prospective case series of 60 people by Cummins et al. (2018) was an observational registry study done in the UK. This study reported on the use, outcomes, and complications of ECCO2R. The co-primary efficacy and safety outcomes were discharge home or transferred alive from hospital offering ECCO2R, and AEs including procedure-related complications.
Table 2 presents study selection details.
Study no. | First author, date, country | People (male: female) | Age (years) | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|---|
1 | Millar 2022, UK | n=531 in RCTs, n who had ECCO2R=244 n=826 in other studies, n who had ECCO2R=571 (Genders not recorded) | Average (mean or median) 35 to 68 across studies | Systematic review and meta-analysis | AHRF of any cause treated with ECCO2R | ECCO2R | 90 days |
2 | Yu 2021, US | n=826, n who had ECCO2R=497 (Genders not recorded) | Not recorded | Systematic review and meta-analysis | Any indication for ECCO2R | ECCO2R | 90 days |
3 | McNamee 2021, UK | n=412 (65% male, 35% female) | Mean 60.2 | RCT | Moderate or severe AHRF, receiving IMV for less than 7 days | vvECCO2R | 90 days |
4 | Boyle 2022, UK | n=412 (65% male, 35% female) | Mean 60.2 | RCT (secondary outcomes of study 3) | Moderate or severe AHRF, receiving IMV for less than 7 days | vvECCO2R | 2 years |
5 | Bein 2013, Germany | n=79, n who had ECCO2R=40 (86% male, 14% female) | Mean 49.8 | RCT | ARDS, receiving MV for less than 7 days | avECCO2R | 60 days |
6 | Barrett 2022, UK | n=18, n who had ECCO2R=9 (56% male, 44% female) | Mean 67.5 | RCT | Acute exacerbation COPD, leading to hypercapnic respiratory failure | vvECCO2R plus NIV | 90 days |
7 | Combes 2019a, Europe and Canada | n=95 (67.4% male, 32.6% female) | Mean 60.2 | Prospective case series | Moderate ARDS, expected to have IMV more than 24 hours | vvECCO2R | 28 days |
8 | Combes 2019b, Europe and Canada | n=95 (67.4% male, 32.6% female) | Mean 60.2 | Prospective case series (secondary analysis of study 7) | Moderate ARDS, expected to have IMV more than 24 hours | vvECCO2R | 28 days |
9 | Cummins 2018, UK | n=60 (58.3% male, 41.7% female) | Median 58 | Observational registry study | Any indication to have ECCO2R in the UK | ECCO2R | Hospital discharge |
Procedure technique
Of the 9 studies, 1 study reported on avECCO2R exclusively, 5 studies reported on vvECCO2R exclusively, and 3 studies reported on both together.
Efficacy
Mortality
All 9 included studies reported on mortality outcomes, however studies varied in the timepoints at which they chose to report mortality. No study showed a statistically significant difference in mortality at any point for ECCO2R intervention groups compared with control groups.
In the systematic review and meta-analysis of 531 people with AHRF across 3 RCTs who had ECCO2R compared with standard care, there was no significant difference in 30-day mortality (37% for ECCO2R compared with 35% for standard care; p=0.73) or in-hospital mortality (34% for ECCO2R compared with 29% for standard care; p>0.05). 90-day mortality was only measured in 1 RCT (42% for ECCO2R compared with 40% for standard care). The observational studies in this review used a range of mortality timepoints. Reported mortality in the observational studies ranged from 38% to 59%.
In the systematic review and meta-analysis of 826 people who had ECCO2R for any indication, there was no significant difference in in-hospital mortality for vvECCO2R compared with avECCO2R (27% compared with 36%; p=0.26).
In the RCT of 412 people with moderate or severe AHRF who were allocated to have ECCO2R compared with standard care, there was no significant difference in unadjusted 90-day mortality (42% compared with 40%; p=0.68) or 28-day mortality (38% compared with 36%; p=0.64). In the study reporting on long-term outcomes from the same RCT of 412 people, there was no significant difference in 6-month mortality (43% compared with 42%; p=0.83), 1-year mortality (44% compared with 43%; p=0.83) or 2-year mortality (47% compared with 48%, p=0.89).
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, there was no significant difference in in-hospital mortality (18% compared with 15%; p=1.00).
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD there was no significant difference in survival between ECCO2R and NIV at any timepoint out to 90 days (p>0.05).
In the prospective case series of 95 people with ARDS, the 28-day mortality was 27%. The in-hospital mortality was 38%. The paper reporting on the secondary analysis of this study did not make further comments about mortality.
In the observational registry study of 60 people who had ECCO2R for any indication, the in-hospital mortality was 55%.
ICU and hospital length of stay
5 studies reported on ICU and hospital length of stay outcomes.
In the systematic review and meta-analysis of 531 people across 3 RCTs who had ECCO2R for AHRF, ECCO2R had small mean relative effects on ICU length of stay (17 days compared with 15 days) and hospital length of stay (24 days compared with 22 days) compared with standard care. However this was not significant as the 95% credible intervals for both ICU and hospital length of stay spanned a mean difference of 0 days.
In the systematic review and meta-analysis of 826 people who had ECCO2R for any indication, ICU length of stay for people who had vvECCO2R was significantly shorter than for those who had avECCO2R (15 days compared with 42 days; p=0.05).
In the RCT of 412 people with moderate or severe AHRF comparing ECCO2R with standard care, there was no significant difference in median ICU length of stay (14 days compared with 13 days; p=0.67) or median hospital length of stay (22 days compared with 18 days; p=0.65).
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, there was no significant difference in ICU length of stay (31 days compared with 23 days; p=0.14) or hospital length of stay (47 days compared with 35 days; p=0.11). In the subgroup with starting PaO2/FiO2 less than 150 there were no significant differences in ICU length of stay (p=0.26) or hospital length of stay (p=0.82).
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD who had ECCO2R compared with controls who had NIV, the people on ECCO2R had a significantly longer ICU length of stay (162 hours compared with 46 hours; p<0.05) and hospital length of stay (240 hours compared with 124 hours; p<0.05). Differences in the care protocole between the techniques contributed to the longer ICU stay. With NIV, patients could be weaned off at any time including overnight. The protocol for ECCO2R did not allow weaning overnight. Four out of 9 people in the control group declined NIV and were discharged to a regular hospital ward from ICU regardless of blood gas results. This also contributed to a shorter ICU length of stay in the control group.
Duration of MV and NIV
5 studies reported on duration of MV and NIV.
In the systematic review and meta-analysis of 531 people across 3 RCTs who had ECCO2R for AHRF, a meta-analysis of the 2 RCTs reporting VFDs at day 28 showed that people randomised to ECCO2R had fewer VFDs (7.6 days compared with 9.2 days; mean difference −1.4 days; 95% CI −3.6 to 0.9).
In the RCT of 412 people with moderate or severe AHRF comparing ECCO2R with standard care the intervention group had significantly fewer VFDs than the ventilation-alone control group (7 days compared with 9 days; p=0.02). There was no significant difference between the groups in the duration of ventilation in survivors (18 days compared with 17 days; p=0.83)
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, there were no significant differences in VFDs at day 28 (10 days compared with 9 days; p=0.78) or day 60 (33 days compared with 29 days; p=0.47). However, a post-hoc analysis showed that surviving people with more severe hypoxia (initial PaO2/FiO2 less than 150 at randomisation) who had ECCO2R had more VFDs compared with controls at day 60 (41 days compared with 28 days; p=0.033).
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD who had ECCO2R or standard care, time to NIV discontinuation was significantly shorter with ECCO2R compared with controls (7 hours compared with 25 hours; p=0.004). No one in either group underwent IMV while they were on therapy.
In the prospective case series of 95 people with ARDS, the average duration of IMV was 17 days. The average number of VFDs was 11 days.
Changes in concentration of blood gases
6 studies reported on changes in concentration of blood gases.
In the systematic review and meta-analysis of 826 people comparing vvECCO2R with avECCO2R for any indication, there were no significant changes in PaCO2 after 72 hours for vvECCO2R (64 mmHg compared with 49 mmHg; p=0.54) and avECCO2R (59 mmHg compared with 48 mmHg; p=0.17). There were no significant changes in pH, PaO2, or PaO2/FiO2 in either group (p>0.05).
In the RCT of 412 people with moderate or severe AHRF comparing ECCO2R with standard care, the ECCO2R group had a lower PaO2/FiO2 ratio on day 2 (148 compared with 161) and on day 3 (148 compared with 167). PaCO2 was higher in the ECCO2R group from day 2 onwards, and pH was lower in the ECCO2R group (7.29 compared with 7.32 at day 2, 7.32 compared with 7.35 at day 3).
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD, PaCO2 was significantly lower with ECCO2R compared with NIV at 4 hours after randomisation (6.8 mmHg compared with 8.3 mmHg; p=0.02).
In the prospective case series of 95 people with ARDS, in the intervention group PaCO2 and PaO2/FiO2 remained stable compared with baseline.
In the observational registry study of 60 people who had ECCO2R for any indication, the study recorded the best value of blood gases after 24 hours of ECCO2R compared with the worst value in the 6 hours pretreatment. PaCO2 was significantly decreased (7 kPa compared with 11 kPa; p<0.001), PaO2 was significantly decreased (9 kPa compared with 11 kPa; p<0.004) but there was no significant difference in PaO2(kPa)/FiO2 (0.17 compared with 0.17; p>0.05).
Change in MV settings from baseline
7 studies reported on changes in MV settings.
In the systematic review and meta-analysis of 531 people across 3 RCTs who had ECCO2R for AHRF, the authors noted a wide variation in consistency of reporting, the choice of variables, and the timepoints at which they were measured.
In the systematic review and meta-analysis of 826 people comparing vvECCO2R with avECCO2R for any indication, PEEP was significantly higher in the vvECCO2R group at 72 hours compared with the avECCO2R group (p<0.05).
In the RCT of 412 people with moderate or severe AHRF comparing ECCO2R with standard care, the group allocated to have ECCO2R had a lower tidal volume at day 3 (4.4 ml/kg compared with 6.7 ml/kg).
In the prospective case series of 95 people with ARDS, tidal volume, minute ventilation, plateau pressure and driving pressure were significantly lower at 8 hours and 24 hours compared with baseline (p=0.001), but the exact figures are not recorded in the paper.
The observational registry study of 60 people who had ECCO2R for any indication in the UK recorded the best value of ventilator settings after 24 hours of ECCO2R compared with the worst value in the 6 hours pretreatment. PEEP significantly increased after treatment (10 cmH2O compared with 8 cmH2O; p=0.032).
Safety
Overall complications
Overall complication rates were reported in 6 studies.
In the RCT of 412 people with moderate or severe AHRF, 168 AEs occurred in 106 people (53%) in the intervention arm, of which 65 AEs were considered related to the study intervention. 70 of these AEs were classed as serious SAEs in 62 people (31%). 22 SAEs were considered related to the study intervention.
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, the overall incidence of avECCO2R-related AEs was 7.5%.
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD, there were no severe or life-threatening complications in either group. There were 9 ECCO2R-related AEs.
In the prospective case series of 95 people with ARDS, ECCO2R-related AEs were reported in 37 people (39%). Six SAEs were reported, 2 SAEs were considered attributable to ECCO2R (massive right frontal parenchymal haematoma, pneumothorax at cannula insertion in the jugular vein). The secondary analysis of this study comparing low CO2 extraction capacity devices with high CO2 extraction capacity devices showed there was no significant difference in the incidence of ECCO2R-related AEs between the low extraction and the high extraction devices (48% compared with 34%; p=0.242).
In the observational registry study of 60 people who had ECCO2R for any indication, 19 people (32%) experienced complications. This study did not specify if the complications were AEs or SAEs.
Haemorrhage
Haemorrhage rates were reported in 8 studies.
In the systematic review and meta-analysis of 531 people with AHRF across 3 RCTs, and 826 people across 18 observational studies, a meta-analysis was not possible because of lack of consistent definitions of haemorrhage. In the 2 RCTs that reported haemorrhage rates, bleeding appeared to be more frequent in the ECCO2R arms (17% compared with 1%), as was intracranial haemorrhage, but this was not statistically significant (5% compared with 1%; RR 3.00; 95% CI 0.42 to 20.51).
In the RCT of 412 people with moderate or severe AHRF, in the ECCO2R arm 17 people (8%) had bleeds (excluding intracranial haemorrhage), 6 of these (35%) were classed as SAEs. In the control arm, 3 people (1%) had bleeds (excluding intracranial haemorrhage), 1 of these was classed as an SAE. Of the SAEs in the ECCO2R arm, 4 were considered to be at least possibly related to the intervention. In the ECCO2R arm, 10 people (5%) developed intracranial haemorrhage, 9 of these were classed as SAEs, compared with 3 people (1%) and 1 SAE in the control arm. Of the SAEs in the ECCO2R arm, 5 were considered to be at least possibly related to the intervention. There was a recruitment pause in the trial for investigation of a fatal intracranial haemorrhage.
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, they reported that the number of units of red blood cells transfused in the 10 days after randomisation was significantly higher in the avECCO2R group than controls (4 units compared with 2 units; p<0.05).
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD, there were 3 AEs of cannula site bleeding and 3 AEs of haemolysis. There was no major bleeding in either group, but 1 person with ECCO2R had a pool of platelets.
In the prospective case series of 95 people with ARDS, bleeding events occurred in 13 people (14%). Three were related to cannula insertion, 7 were at the cannula site. Six of these bleeds were SAEs. One bleeding SAE was considered attributable to ECCO2R (massive right frontal parenchymal haematoma). The secondary analysis of this trial comparing low CO2 extraction capacity devices with high CO2 extraction capacity devices showed that bleeding rates were significantly higher in the low extraction capacity device group (27% compared with 6%; p<0.01). The 1 bleeding SAE attributable to ECCO2R occurred in a person in the low CO2 extraction capacity device group.
In the observational registry study of 60 people who had ECCO2R for any indication in the UK, 10 people experienced bleeding complications. Seven were cannulation site bleeding, 1 was a gastrointestinal haemorrhage, 1 was haemolysis, and 1 was surgical site bleeding. This study did not specify if the complications were AEs or SAEs.
Limb ischaemia
Limb ischaemia rates were reported in 4 studies.
In the systematic review and meta-analysis of 531 people with AHRF across 3 RCTs, and 826 people across 18 observational studies, 2 RCTs reported rates of limb ischaemia with incidence of 3% and 10%. Four observational studies reported rates of limb ischaemia, ranging from 0% to 14%. A meta-analysis of these results was not possible due to the range in definitions of limb ischaemia.
In the systematic review and meta-analysis of 826 people comparing vvECCO2R with avECCO2R for any indication, in the avECCO2R group (n=329) 14 people (4%) developed limb ischaemia. The figures for vvECCO2R were not reported.
In the RCT of 412 people with moderate or severe AHRF, the paper did not specifically report limb ischaemia.
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, transient ischaemia of the lower limb occurred in 1 person (3%).
Circuit complications
This set of outcomes (incorporating clotting, device failure, and infection) was reported in 7 studies.
In the systematic review and meta-analysis of 531 people with AHRF across 3 RCTs, and 826 people across 18 observational studies, circuit complications were reported in 2 RCTs (4% to 19% incidence) and 6 observational studies (17% to 72% incidence). Because of variable reporting, a meta-analysis was not possible.
In the systematic review and meta-analysis of 826 people comparing vvECCO2R with avECCO2R for any indication, in the avECCO2R group 27 people developed an arterial thrombus despite sufficient anticoagulation. The paper did not report the incidence of these complications in the vvECCO2R group.
In the RCT of 412 people with moderate or severe AHRF, device failure occurred in 9 people (4.5%), leading to an SAE in 2 people. In the ECCO2R arm infectious complications occurred in 7 people (4%) leading to 2 SAEs, the control arm had 1 person (1%) with infectious complications not leading to an SAE. In the ECCO2R arm, 4 people (2%) developed heparin-induced thrombocytopenia, 1 of these was an SAE.
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD, there was 1 AE of device failure.
In the prospective case series of 95 people with ARDS who had ECCO2R, membrane lung clotting occurred in 13 people. Six of these events led to circuit changes, and 7 events led to ECCO2R discontinuation. Haemolysis occurred in 11 people, infectious complications in 2 people, thrombocytopenia in 12 people, and hypofibrinogenemia in 2 people. In the secondary analysis of this study comparing low CO2 extraction capacity devices with high CO2 extraction devices, haemolysis was significantly more common in the low capacity device group (21% compared with 6%; p<0.05).
In the observational registry study of 60 people who had ECCO2R for any indication in the UK, 7 people (12%) had mechanical complications with the device. Five people (8%) developed culture-proven infection, but it was not specified if this was related to the intervention.
Cannulation complications
Cannulation complication rates were reported in 7 studies. This set of outcomes includes pseudoaneurysm formation, vascular injury, and catheter displacement. Cannulation-related bleeding is covered in the haemorrhage section.
In the systematic review and meta-analysis of 531 people with AHRF across 3 RCTs, and 826 people across 18 observational studies, 2 RCTs reported on cannulation complications (4% to 5% incidence) and 7 observational studies reported on cannulation complications (2% to 40% incidence).
In the systematic review and meta-analysis of 826 people comparing vvECCO2R with avECCO2R for any indication, 1 person on avECCO2R developed pseudoaneurysm of the femoral artery.
In the RCT of 79 people with ARDS comparing avECCO2R with standard care, 2 people in the intervention arm (n=40) developed pseudoaneurysms as a result of arterial cannulation.
In the RCT of 18 people with acute hypercapnic respiratory failure because of COPD, there was 1 ECCO2R cannula thrombosed prior to the intervention that was changed without an AE.
In the prospective case series of 95 people with ARDS who had ECCO2R, 1 person developed an SAE of pneumothorax at cannula insertion in the internal jugular vein, which was considered attributable to ECCO2R. The secondary analysis of this study showed that this SAE occurred in 1 person in the high CO2 extraction capacity device group.
Pneumothorax
Pneumothorax rates were reported in 2 studies.
In the prospective case series of 95 people with ARDS who had ECCO2R, 1 person developed an SAE of pneumothorax at cannula insertion in the internal jugular vein. The secondary analysis of this study showed that this SAE took place when a high CO2 extraction capacity device was used.
In the observational registry study of 60 people who had ECCO2R for any indication in the UK, 1 person developed pneumothorax requiring treatment.
Need for dialysis
Need for dialysis was reported in 1 study.
In the observational registry study of 60 people who had ECCO2R for any indication in the UK, 5 people (8%) needed haemofiltration.
Other
In the RCT of 412 people with moderate or severe AHRF, in the ECCO2R arm 1 person (1%) had an ischaemic stroke classed as an SAE, compared with 3 people (1%) with 3 SAEs in the control arm.
Anecdotal and theoretical AEs
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other AEs for this procedure that they had heard about (anecdotal) that were not reported in the literature. They were also asked if they thought there were other AEs that might possibly occur, even if they had never happened (theoretical). They did not list any anecdotal or theoretical AEs.
Four professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
No study showed a significant difference in mortality at any point for ECCO2R intervention groups compared with control groups.
NICE's previous interventional procedures guidance on this procedure indicated that guidance should be reviewed when the results of the REST trial by McNamee et al. (2021) were published. This trial did not show a significant difference in 90-day mortality between ECCO2R and standard care. There were no significant differences between ECCO2R and standard care in ICU length of stay or hospital length of stay, however the ECCO2R group had more VFDs. This trial was paused while a fatal intracranial bleed was being investigated, and the trial was stopped early due to futility to detect a clinically important difference in 90-day mortality between groups. The study only recruited 412 people from a planned sample size of 1,120. 10% of people in the intervention arm of this trial experienced an SAE relating to the intervention. 5% of people experienced an intracranial bleed classified as an SAE.
The 2 largest RCTs in this overview were stopped early due to futility to detect a clinically important difference in the primary outcome.
The RCT of 79 people was conducted in 2013. The standards of technology may have changed since then.
Studies had a wide range in reporting of outcomes, and how they classified AEs. This limits the ability to compare outcomes and AEs across studies.
Studies varied in their inclusion criteria. Some studies recruited moderate or severe AHRF but did not specify ARDS, while others recruited people with ARDS. Only 1 study by Barrett et al. (2022) examined acute hypercapnic respiratory failure because of an acute exacerbation of COPD. Some studies have varying definitions of ARDS, reflecting a change in international consensus on diagnostic criteria.
One study exclusively looked at avECCO2R, some studies have grouped together findings for all ECCO2R techniques. avECCO2R is largely being replaced by vvECCO2R.
One study indicated that the rates of haemorrhage-related complications are lower when a high CO2 extraction capacity device is used compared with a low CO2 extraction capacity device.
Generally, most people meeting the inclusion criteria were excluded from studies. This reflects standard clinical practice as ECLS is a scarce resource with a wide range of exclusion criteria necessitating very careful patient selection. This could limit the generalisability of these studies, however the committee could consider how this compares with standard clinical practice in the allocation of ECLS.
Where RCTs have taken place, the control groups were well-characterised, and matched the intervention group in key demographics. However the study designs for RCTs did not protocolise standard care.
The minimum follow-up duration across studies was 28 days or hospital discharge. Most studies reported in the range of 30 to 90 day outcomes, however only 1 study reported outcomes beyond 90 days.
4 co-authors of the systematic review and meta-analysis of 1,357 people are co-authors of the RCT of 412 people. 2 of these co-authors have grants for the conduct of this RCT.
The RCT of 412 people had ECCO2R devices, catheters and consumables provided free of charge by the manufacturer. Two of the authors received grants from the manufacturer during the study, 1 author received non-financial support from the manufacturer in provision of equipment and consumables to undertake a clinical trial of ECCO2R. Two of the authors of the RCT of 79 people were consultants for the manufacturer and received honoraria. The RCT of 18 people was funded by the manufacturer, the institution of the lead author had received funding from the manufacturer. Four authors of the case series of 95 people received research support or personal fees from a manufacturer, 1 was on a manufacturer's medical advisory board at the time of the study. In the case series of 60 people, 2 co-authors were undertaking a clinical trial with contributions from a manufacturer, and 1 co-author had received educational and research funding from a manufacturer.
There are numerous ongoing studies relating to the procedure, including those listed below:
Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R (NCT05079009) Estimated enrolment: 10 people. Study start date: 28 January 2022. Estimated study completion date: February 2023.
Novel ECCO2R Device for Hypercapnic Respiratory Failure (NCT05316532) Estimated enrolment: 60 people. Estimated study start date: 1 January 2023. Estimated study completion date: 31 December 2023. Not yet recruiting.
ECCO2R to facilitatE earLy libEration From mechanicAl Ventilation in patients With Copd Acute Exacerbation (RELEASE) (NCT04147104) Estimated enrolment: 90 people. Estimated study start date: February 2021 Estimated study completion date: June 2023. Not yet recruiting.
ECCO2R in the Treatment of Acute Exacerbation of COPD With Severe Hypercapnia (NCT04842344) Estimated enrolment: 176 people. Estimated study start date: 1 May 2021. Estimated study completion date: 31 March 2024. Recruiting.
ECCO2R - Mechanical Power Study (NCT03939260) Estimated enrolment: 15 people. Study start date: 20 March 2019. Estimated study completion date: March 2024. Recruiting.
Post-Market Study of Low-flow ECCO2R Using PrismaLung+ (NCT04617093) Estimated enrolment: 50 people. Study start date: 30 April 2021. Estimated study completion date: 31 August 2023. Recruiting.
Early Extubation by ECCO2R Compared to IMV in Patients With Severe Acute Exacerbation of COPD (NCT03584295) Estimated enrolment: 192 people. Study start date: 7 February 2023. Estimated study completion date: March 2026. Recruiting.
CO2 Removal in Severe Acute Exacerbations of Chronic Obstructive Lung Diseases (NCT05546606) Estimated enrolment: 304 people. Study start date: 1 November 2022. Estimated study completion date: 31 October 2025. Not yet recruiting.
Extracorporeal CO2 Removal for Acute Decompensation of COPD (ORION) (NCT04582799) Estimated enrolment: 284 people. Study start date: 1 June 2023. Estimated study completion date: 1 June 2026. Not yet recruiting.
Use of Extracorporeal CO2 Removal in Case of Moderate to Severe ARDS to Apply an Ultraprotective Mechanical Ventilation Strategy (NCT04556578) Estimated enrolment: 20 people. Study start date: 16 February 2021 Estimated study completion date: 16 February 2025. Recruiting.
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