resQCPR FDA Approval

[paramedicmike]

The US FDA has approved the resQCPR device for use. It's a two piece device consisting of a compression assist device and an impedance threshold device.

Anybody using it? Seen it used? Seen any changes in your code results?

Just curious. We don't have it around here.

[island emt]

we trialed the ITD a few years back when it first hit the streets . Not sure of the difference it made clinically .

saw the resqcpr device at a trade show two years ago used on a manikin . Think large suction cup with a T handle on top.

Push down for compressions and pull up to cause a negative pressure in the thoracic cavity.

Haven't seen the blind study results on positive / negative results in return to normal perfusing rhythm and lowered morbidity rate.

[systemet]

I don't think it works.

http://www.ncbi.nlm.nih.gov/pubmed/21879897 [Link to free .pdf on page]

N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.

A trial of an impedance threshold device in out-of-hospital cardiac arrest.

Aufderheide TP¹, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators.

BACKGROUND:

The impedance threshold device (ITD) is designed to enhance venous return and cardiac output during cardiopulmonary resuscitation (CPR) by increasing the degree of negative intrathoracic pressure. Previous studies have suggested that the use of an ITD during CPR may improve survival rates after cardiac arrest.

METHODS:

We compared the use of an active ITD with that of a sham ITD in patients with out-of-hospital cardiac arrest who underwent standard CPR at 10 sites in the United States and Canada. Patients, investigators, study coordinators, and all care providers were unaware of the treatment assignments. The primary outcome was survival to hospital discharge with satisfactory function (i.e., a score of ≤3 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating greater disability).

RESULTS:

Of 8718 patients included in the analysis, 4345 were randomly assigned to treatment with a sham ITD and 4373 to treatment with an active device. A total of 260 patients (6.0%) in the sham-ITD group and 254 patients (5.8%) in the active-ITD group met the primary outcome (risk difference adjusted for sequential monitoring, -0.1 percentage points; 95% confidence interval, -1.1 to 0.8; P=0.71). There were also no significant differences in the secondary outcomes, including rates of return of spontaneous circulation on arrival at the emergency department, survival to hospital admission, and survival to hospital discharge.

CONCLUSIONS:

Use of the ITD did not significantly improve survival with satisfactory function among patients with out-of-hospital cardiac arrest receiving standard CPR. (Funded by the National Heart, Lung, and Blood Institute and others; ROC PRIMED ClinicalTrials.gov number, NCT00394706.).

[rock_shoes]

I don't think it works.

http://www.ncbi.nlm.nih.gov/pubmed/21879897 [Link to free .pdf on page]

N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.

A trial of an impedance threshold device in out-of-hospital cardiac arrest.

Aufderheide TP¹, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators.

BACKGROUND:

The impedance threshold device (ITD) is designed to enhance venous return and cardiac output during cardiopulmonary resuscitation (CPR) by increasing the degree of negative intrathoracic pressure. Previous studies have suggested that the use of an ITD during CPR may improve survival rates after cardiac arrest.

METHODS:

We compared the use of an active ITD with that of a sham ITD in patients with out-of-hospital cardiac arrest who underwent standard CPR at 10 sites in the United States and Canada. Patients, investigators, study coordinators, and all care providers were unaware of the treatment assignments. The primary outcome was survival to hospital discharge with satisfactory function (i.e., a score of ≤3 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating greater disability).

RESULTS:

Of 8718 patients included in the analysis, 4345 were randomly assigned to treatment with a sham ITD and 4373 to treatment with an active device. A total of 260 patients (6.0%) in the sham-ITD group and 254 patients (5.8%) in the active-ITD group met the primary outcome (risk difference adjusted for sequential monitoring, -0.1 percentage points; 95% confidence interval, -1.1 to 0.8; P=0.71). There were also no significant differences in the secondary outcomes, including rates of return of spontaneous circulation on arrival at the emergency department, survival to hospital admission, and survival to hospital discharge.

CONCLUSIONS:

Use of the ITD did not significantly improve survival with satisfactory function among patients with out-of-hospital cardiac arrest receiving standard CPR. (Funded by the National Heart, Lung, and Blood Institute and others; ROC PRIMED ClinicalTrials.gov number, NCT00394706.).

Bingo. I participated in this study. The ITD was of no benefit and actually had slightly worse ROSC rates in absolute numbers (not statistically significant).

[Bullets]

Yeah i thought RoC PRIMED had to cut the study on ITD short because it was doing so bad. So an unproven and a toilet plunger are supposed to improve outcomes?

[triemal04]

Yeah i thought RoC PRIMED had to cut the study on ITD short because it was doing so bad. So an unproven and a toilet plunger are supposed to improve outcomes?

Yes. And it's very easy to understand why people will market shit like this, AND why people will buy/use it.

One, because it's always such an ego boost to be able to tell people you are using all these fancy toys that nobody else is...because, you know...you CARE about people and are such a GOOD department.

Two, because to actually change things to make a difference in cardiac arrest requires some effort. And fuck effort, ain't nobody got time for that!

King County used to stand out with very high resuscitation rates (using Utstein criteria); for the last few years more departments have been getting up to very similar levels; Rochester MN, I believe Wake County, and several others that slip my mind right now. Generally, all these places like to announce that they've reached such a level (justifiable in my opinion), and when they do they also tend to mention HOW they reached that level.

Anyone want to guess how? It wasn't with a bunch of bullshit toys.

Citizen CPR programs.

Early dispatcher CPR.

Major emphasize and strict adherance to quality CPR with very limited interruptions.

High level care post resuscitation also matters, as does getting the patient to the right hospital, but any department that can do the second two things, or better yet all threee, will see a jump in the survival rate, overall, and using Utstein.

Any department that wants to invest in flash and toys instead of what actually matters deserves nothing more than contempt.

[Just Plain Ruff]

Any department that wants to invest in flash and toys instead of what actually matters deserves nothing more than contempt.

But what will they do with all the money they have to spend, if not for the newest and greatest toys???