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Impedance Threshold Device

Question Type:
Intervention
Full Question:
Among adults who are in cardiac arrest in any setting  (P), does does use of an inspiratory ITD during CPR  (I), compared with compared with no ITD  (C), change Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC (O)?
Consensus on Science:
ITD Plus Conventional CPR (I) Versus Conventional CPR (C) For the critical outcome of neurologically favorable survival at hospital discharge (assessed with modified Rankin Scale [mRS] score of 3 or less), there was 1 RCT(Aufderheide 2011, 798) of high quality in 8718 OHCAs that was unable to demonstrate a clinically significant benefit from the addition of the ITD to conventional CPR (RR, 0.97; 95% CI, 0.82–1.15). For the critical outcome of survival to hospital discharge, there was 1 RCT(Aufderheide 2011, 798) of high quality in 8718 OHCAs that was unable to demonstrate a clinically significant benefit from the addition of the ITD to conventional CPR (RR, 1; 95% CI, 0.87–1.15). ITD Plus ACD CPR (I) Versus ACD CPR (C) For the critical outcome of neurologically favorable survival, there were no studies identified that compared the use of ITD with ACD CPR with ACD CPR in cardiac arrests. For the critical outcome of survival to hospital discharge, there were 2 RCTs(Plaisance 2000, 989; Plaisance 2004, 265) of very low quality (downgraded for serious imprecision and very serious indirectness because of pre-2000 resuscitation practices) that that were unable to demonstrate a clinically significant benefit from the addition of the ITD to ACD CPR in a total of 421 OHCAs (RR, 0.91; 95% CI, 0.07–12.7(Plaisance 2000, 989) and RR, 1.25; 95% CI, 0.5–3.1).(Plaisance 2004, 265) ITD Plus ACD CPR (I) Versus Conventional CPR (C) For the critical outcome of neurologically favorable survival (CPC ≤2) at 12 months, there was 1 publication reporting results from a randomized study(Frascone 2013, 1214) of very low quality (downgraded for very serious risk of bias and serious imprecision) in 2738 OHCAs that was unable to demonstrate a clinically significant benefit from the addition of the ITD to ACD CPR (when compared with conventional CPR: RR, 1.34; 95% CI, 0.97–1.85). For the critical outcome of neurologically favorable survival at hospital discharge, there was 1 RCT(Frascone 2013, 1214) that incorporated the presumed cardiac etiology subset published in 2011(Aufderheide 2011, 301) of very low quality (downgraded for very serious risk of bias, serious inconsistency, and serious imprecision) in 2738 OHCAs that was unable to demonstrate a clinically significant benefit (using CPC ≤2) from the addition of the ITD to ACD CPR (when compared with conventional CPR: RR, 1.28; 95% CI, 0.98–1.69). Similar data (neurologically intact survival at hospital discharge) were also reported that used mRS of 3 or less, and were unable to demonstrate a clinically significant benefit (lower CI was 3 more/1000 in Frascone [number needed to treat, NNT, of 333] and 6 more/1000 [NNT of 167] in Aufderheide).(Aufderheide 2011, 301; Frascone 2013, 1214) For the critical outcome of survival to 12 months, there were 2 publications reporting results from a single randomized study,(Frascone 2013, 1214) which incorporated the presumed cardiac etiology subset published in 2011,(Aufderheide 2011, 301) of very low quality (downgraded for very serious risk of bias and serious imprecision) in 2738 OHCAs that was unable to demonstrate a clinically significant benefit from the addition of the ITD to ACD CPR (when compared with conventional CPR): Frascone: RR, 1.39 (95% CI, 1.04¬–1.85; lower CI was 2 more/1000; NNT, 500); Aufderheide: RR, 1.49 (95% CI, 1.05–2.12; lower CI was 4 more/1000; NNT, 250). For the critical outcome of survival to hospital discharge, there were 3 publications reporting results from 2 randomized studies(Wolcke 2003, 2201; Aufderheide 2011, 301) (which incorporated the presumed cardiac etiology subset published in 2011 (Aufderheide 2011, 301)) of very low quality (downgraded for very serious risk of bias, serious indirectness, and serious imprecision) in a total of 2948 OHCAs that were unable to demonstrate a clinically significant benefit from the addition of the ITD to ACD CPR (when compared with conventional CPR): Frascone: RR, 1.17 (95% CI, 0.94–1.45); Aufderheide: RR, 1.26 (95% CI, 0.96–1.66); Wolcke: RR, 1.41 (95% CI, 0.75–2.66).
Treatment Recommendation:
We recommend against the routine use of the ITD in addition to conventional CPR (strong recommendation, high-quality evidence). A consensus recommendation could not be reached for the use of the ITD when used together with ACD CPR. Values, Preferences, and Task Force Insights In making a recommendation against the routine use of the ITD alone, we place a higher value on not allocating resources to an ineffective intervention over any yet-to-be-proven benefit for critical or important outcomes. Because of the concern about allocating resources to an intervention with equivocal benefit for critical or important outcomes, a consensus recommendation could not be reached for ITD combined with ACD CPR. The task force thought that the decision on use of the ITD plus ACD combination should be left to individual Council guidelines. Public comments posted online were reviewed and considered by the task force, specifically regarding the use of the ITD and ACD CPR combination and the task force’s interpretation of the data from 2 publications from the same study(Aufderheide 2011, 301; Frascone 2013, 1214) using the GRADE process, and how the data from these studies had been analyzed and interpreted. The task force received feedback from the investigator(s) of this study in the public commenting period and in an open session. In addition, it considered an editorial on the analysis of this study(Prescott 2013, 1161) and discussed the publications(Aufderheide 2011, 301; Frascone 2013, 1214) and their clinical significance in its closed sessions. The NNTs were discussed and the use of the CI closest to unity as a measure of study precision. It was also noted that the critical and important endpoints for this and the other ALS PICO questions were agreed a priori and posted for public commenting before searches took place, hence the difference in our hierarchy of outcomes compared with the actual primary and secondary outcomes reported in the study that made up the 2 publications. The task force appreciated the challenges of studying a combined intervention and conducting a large cardiac arrest study. There was also discussion of the involvement of the manufacturer in the design and reporting of the study and that sponsorship of drug and device studies by manufacturers can lead to more favorable results and conclusions.(Lundh 2012, MR000033) There was considerable debate on this topic in both closed and open task force sessions such that a consensus could not be achieved by the task force on a treatment recommendation for the use of the ITD when used together with ACD CPR.
CoSTR Attachments:
ITDACDvsACDEP1May2014.pdf    
ITDACDvsStandard2May2014.pdf    
ITDnoITD2May2014.pdf    

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