Advanced Circulatory ResQCRP ResQPUMP ACD-CPR Інструкція із застосування - Сторінка 2

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FORCE GAUGE CALIBRATION

If the zero reading of the force gauge (Figure 16) has drifted away from the zero line, the gauge

should be readjusted prior to further use as follows:

1. Remove the suction cup by pulling it from the stem of the handle.

2. Use a Phillips screwdriver to loosen the screw at the top of the connection stem (Figure 17)

with a firm turn. Remove the nylon stem and washer located inside the stem (Figure 18).

3. Insert a straight blade screwdriver (4 mm [1/8"] wide) in threaded hole at the end of the

spring/plunger assembly and catch the slot of the adjustment screw seated about 3 cm (1")

down inside the brass plunger (Figure 18).

4. Loosen the screw. If there is excessive resistance, heat the screw slightly using a hairdryer to

soften the locking resin (Figure 19).

5. Loosen the screw and adjust it until the gauge is on the zero line (Figure 16). Compress the

spring a few times and check that the zero reading remains correct. Fine readjustment may

be needed. If the screw was heated, wait until it cools to room temperature before proceeding

to the next step.

6. Lock the screw by applying a drop of LOCTITE 242 locking fluid (or equivalent) to top edge

of screw. Use a toothpick to ensure that the fluid is applied directly to the entire top edge of

the screw. Wait ten minutes for the locking fluid to set.

7. Reassemble in reverse order. Place the washer into the nylon stem as shown in Figure 20.

Apply a drop of locking fluid to the tip of the thread near the end of the screw. Push the screw

up though the end of the stem and through the washer.

8. Finally, slip the spring/plunger on the handle down into the stem. Rotate the stem until the slot

in the stem aligns with the rib in the handle and slips all the way into the handle, then tighten

the screw.

9. Wait 24 hours before using the device to ensure that the locking resin obtains full strength.

During this time, the ResQPUMP should be hung by the strap or left resting on the handle

with the suction cup pointing up.

Figure 16

Figure 17

Figure 18

Decompression

LIFT

to 10 kgs

Use enough

force to

COMPRESS

to 2" (5 cm) depth

80/min

Compression

Figure 19

Figure 20

SUMMARY OF PRIMARY CLINICAL STUDY

Study Design and Methods

The ResQTRIAL was a prospective, multi-center, two-arm, randomized, controlled,

partially masked clinical study conducted under 21 C.F.R. §50.24, Exemption from

Informed Consent under Emergency Circumstances, and was funded by a grant from the

National Institutes of Health (NIH). Study oversight was conducted by an independent Clinical

Events Committee responsible for the review of all adverse events and inclusion/

exclusion adjudication and an independent Data Safety Monitoring Board to review

aggregate data to provide recommendations whether or not to continue subject

enrollment.

Rescuers provided CPR using the ResQCPR System at 80 compressions per minute (the S-CPR

group received compressions at the AHA-recommended rate of 100 compressions per minute).

Patients were followed for one year after cardiac arrest to determine if the ResQCPR System

improved survival rates after cardiac arrest. Neurological outcomes were assessed at the time of

hospital discharge, and then 30, 90 and 365 days after cardiac arrest.

The principal data elements that led to device approval were a post hoc analysis of

survival up to one year after cardiac arrest not incorporating the consideration of

neurological function. The primary safety and effectiveness endpoint defined in the

protocol was survival to hospital discharge with favorable neurologic function, defined as

a modified Rankin Scale score (MRS) of ≤ 3. The MRS assessment takes into consideration the

subject's neurologic status both prior to and following cardiac arrest. However,

conclusions and inferences regarding the original prospective primary endpoint for the ResQTRIAL

(i.e., survival with good neurological outcome) cannot be drawn from the ResQTRIAL due to

interpretability issues related to the neurological component of that composite endpoint. The

hypothesis-based secondary safety endpoint was the overall rate of major adverse events through

hospital discharge. The hypothesis-based secondary effectiveness endpoint was long term

neurologic function assessed using the Cognitive Abilities Screening Instrument (CASI, Version

E-1.1) score at 90 and 365 days. CASI is measured on a scale of 0-100, with higher scores

signifying better outcomes.

All subjects in non-traumatic arrest determined by emergency medical services (EMS)

personnel to require CPR according to their local protocols were randomized and treated

in this study. The intention-to-treat (ITT) population was comprised of all subjects randomized to

S-CPR or CPR using the ResQCPR System who met the study enrollment criteria regardless of

the cause of the non-traumatic cardiac arrest. A subset of the ResQTRIAL ITT population was

comprised of patients who had a cardiac arrest of presumed cardiac etiology and who have the

potential to benefit from CPR. This subgroup was defined as the modified intention-to-treat (mITT)

primary analysis population. Baseline demographics and parameters were similar between study

groups as shown in Table 1.

Table1: ResQTRIAL Pivotal Phase Demographics and Baseline Characteristics

S-CPR

Parameter

ITT

mITT

ITT

(n=1201)

(n=813)

(n=1269)

Age, years (mean ± SD)

64.2 ± 17.2

66.8 ± 14.5

63.3 ± 17.8

Male

752 (62.6)

539 (66.3)

803 (63.3)

Race:

White

960 (79.9)

660 (81.2)

1035 (81.6)

Asian

39 (3.2)

31 (3.8)

29 (2.3)

Native Hawaiian/Pacific Islander

4 (0.3)

3 (0.4)

1 (0.1)

American Indian/Alaska Native

18 (1.5)

9 (1.1)

22 (1.7)

Black/African American

152 (12.7)

94 (11.6)

155 (12.2)

Unknown

28 (2.3)

16 (2.0)

26 (2.1)

Ethnicity:

Hispanic/Latino

22 (1.8)

15 (1.8)

32 (2.5)

Not Hispanic/Latino

1149 (95.7)

782 (96.2)

1207 (95.2)

Unknown

30 (2.5)

16 (2.0)

29 (2.3)

Bystander witnessed arrest

517 (43.1)

383 (47.1)

546 (43.2)

EMS witnessed arrest

146 (12.2)

76 (9.4)

144 (11.4)

Unwitnessed arrest

536 (44.7)

353 (43.4)

575 (45.5)

Not available

Bystander CPR

489 (40.7)

350 (43.1)

532 (42.0)

Not available

1 (0.1)

Initial recorded cardiac rhythm:

Ventricular fibrillation/pulseless

294 (24.5)

247 (30.4)

335 (26.4)

ventricular tachycardia

Asystole

597 (49.7)

379 (46.6)

633 (49.9)

Pulseless electrical activity

293 (24.4)

180 (22.1)

284 (22.4)

Not available

7 (0.9)

911 call to EMS CPR start,

6.7 ± 3.5

6.6 ± 3.4

6.7 ± 3.2

minutes

(mean ± SD)

911-to-first study device placed,

7.1 ± 3.5

minutes (mean ± SD)

Duration CPR, minutes (mean ± SD)

25.6 ± 13.0

27.60 ± 12.24

26.3 ± 12.3

Pre-hospital ROSC

490 (40.8)

324 (39.9)

524 (41.3)

Numbers shown are subjects (%) unless otherwise indicated

Does not include subjects with EMS witnessed arrests

ROSC = Return of spontaneous circulation

Safety and Effectiveness Results

Survival

One of the major objectives of the ResQTRIAL was to determine the safety and effectiveness of the

ResQCPR treatment from the time of a return of spontaneous circulation (ROSC) to survival status

one year later; this is shown in Table 2. The results demonstrated that the likelihood of short and

longer-term survival was improved in the ResQCPR arm. At one year, there was a 34% increase

in the survival rate in subjects in the ITT population receiving CPR with the ResQCPR System

compared with S-CPR.

Table 2: Survival of Out-of-Hospital Cardiac Arrest Subjects Subjects from

ROSC to One Year

ITT

S-CPR

ResQCPR

S-CPR

(n=1201)

(n=1269)

(n=813)

ROSC during CPR before hospital

490 (40.8)

524 (41.3)

324 (39.9)

admission

Admitted to hospital

342 (28.5)

381 (30.0)

216 (26.6)

Survived to 24 hours

277 (23.3)

310 (24.6)

176 (21.6)

following arrest

Not available

Alive at hospital discharge

123 (10.3)

150 (11.9)

80 (9.9)

Not alive at hospital discharge

1072

1114

727

Not available

Alive at 30 days

98 (8.3)

131 (10.4)

65 (8.1)

Not alive at 30 days

1086

1123

738

Not available

Alive at 90 days

88 (7.5)

116 (9.3)

58 (7.3)

Not alive at 90 days

1089

1129

740

Not available

Alive at 1 year

68 (5.8)

96 (7.8)

48 (6.0)

Not alive at 1 year

1103

1137

746

Not available

Numbers shown are subjects (%) unless otherwise indicated.

Kaplan Meier survival analyses were performed in the subgroup of subjects who had a return

of spontaneous circulation (ROSC) for both the ITT and mITT populations (where the number of

subjects with ROSC is shown above in Table 1). The findings in these analyses are consistent with

the overall study results. The Kaplan Meier curves in Figure 21 show that the majority of subjects

with ROSC do not survive post-hospitalization out-of-hospital cardiac arrest. However, the Kaplan

Meier estimate of survival at one year was 30% higher in subjects in the ITT population receiving

CPR with the ResQCPR System compared with S-CPR (22.7% vs. 17.5%).

Figure 21: Kaplan Meier Analysis of Subjects with ROSC Following

Out-of-Hospital Cardiac Arrest

Importantly, there was no increase in the number of subjects with severe neurologic impairment

in the ResQCPR group, that is, the neurological outcome in patients who received CPR with the

ResQCPR System appeared to be no worse than the control (S-CPR). In the mITT, proportional

differences between the two treatment groups were observed to become larger over time.

Approximately 50% more subjects receiving CPR with the ResQCPR System were alive one year

after OHCA compared with those treated with S-CPR. However, this comparison was not

prospectively specified or adjusted for multiplicity.

Secondary Safety Endpoint

The analysis of safety was based on the randomized cohort of 2470 subjects in the ITT population

and 1655 subjects in the mITT subgroup available for the evaluation prior to hospital discharge.

The safety analysis included major adverse events that were reported during the pre-hospital

resuscitation effort and up to the point of hospital discharge, as applicable. There were no

differences in overall major adverse event rates between the study groups in the mITT population;

thus the secondary safety endpoint was met. Reported major adverse events by type are shown

in Table 3.

Table 3: ResQTRIAL (Out-of-Hospital Cardiac Arrest) Subjects with Major Adverse

Events Through Hospital Discharge

ResQCPR

Event

ITT

mITT

(n=842)

S-CPR

67.0 ± 15.2

(n= 1201)

559 (66.4)

Subjects with ≥1 major

adverse event through

1129 (94.0)

hospital discharge (sec-

715 (84.9)

ondary safety endpoint

)

19 (2.3)

1 (0.1)

Death

1074 (89.4)

10 (1.2)

Re-arrest

230 (19.2)

88 (10.5)

Stroke/cerebral bleeding

11 (0.9)

9 (1.1)

Internal organ injury

2 (0.2)

19 (2.3)

Hemothorax

3 (0.3)

811 (96.3)

Bleeding requiring

8 (0.7)

12 (1.4)

intervention

400 (47.5)

Cardiac tamponade

4 (0.3)

80 (9.5)

361 (42.9)

Aspiration

20 (1.7)

Pneumothorax

11 (0.9)

358 (42.5)

Seizure

19 (1.6)

0 (0.0)

Rib/Sternal fracture

23 (1.9)

Pulmonary edema

96 (8.0)

292 (34.7)

Numbers shown are subjects with at least one report of the listed adverse event types. If multiple events of same type were

376 (44.7)

reported, the event is only counted once per subject. Reports of deaths, re-arrest, seizure, and pulmonary edema in the field

171 (20.3)

(e.g., pre-hospital) are also shown. All other adverse event types were assessed based on review of medical records for

3 (0.4)

subjects transported to a hospital. There were no Major Adverse Events associated with device malfunctions, defects, or

failures.

6.7 ± 3.2

Secondary safety endpoint: The rate of major adverse events in the ResQCPR group (mITT) was found to be non-inferior to

that in S-CPR group (p < 0.0001) within a non-inferiority margin of 5%.

7.1 ± 3.5

Data shown includes combined pre-hospital and in-hospital reports of pulmonary edema. Pulmonary edema was defined

as any of the following: Pre-hospital reports of advanced airway filled with fluid ≥2 times; blood, mucous, fluid or other

secretions in the airway; reports of pulmonary edema or pleural/pulmonary effusion on post-mortem examinations; and, for

28.10 ± 11.45

subjects transported to a hospital, in-hospital reports of pulmonary edema or pleural/pulmonary effusion confirmed on x-ray

345 (41.0)

or CT scan. Pre-hospital pulmonary edema was reported in 22 patients (2.7%) in the S-CPR group, and in 30 patients (3.6%)

in the ResQCPR group (mITT).

The only difference in adverse events between the two groups was the observation that more

patients receiving CPR with the ResQCPR System had pulmonary edema. A post hoc analysis

appeared to demonstrate that the presence of pulmonary edema did not adversely affect

effectiveness as measured by survival.

Secondary CASI Effectiveness Endpoint

The pre-specified secondary effectiveness endpoint was an evaluation of long-term neurological

function using Mean Cognitive Abilities Screening Instrument (CASI) scores at 90 and 365 days.

The study was not able to demonstrate an improvement in neurologic function in the ResQCPR arm

based upon CASI scores (as was hypothesized); however, CASI scores were not significantly

different among survivors who were discharged from the hospital. The mean scores included

subjects who died after hospital discharge, with a CASI score equal to 0 assigned to those who

died. More than 85% of the one-year survivors in both study arms completed the one-year CASI

assessment and the mean CASI scores for these subjects were 93.7 ± 11.8 (n=30) in the S-CPR

arm and 94.7 ± 4.4 (n=41) in the ResQCPR arm for the mITT population, consistent with full or

mITT

nearly full recovery in both groups; ITT scores were 91.9 ± 13.5 (n=43) in the S-CPR arm and

ResQCPR

92.3 ± 12.3 (n=49) in the ResQCPR arm.. There were only three patients with CASI scores <70,

(n=842)

a score consistent with poor neurological function, in both groups. There is limitation in interpreting

345 (41.0)

the comparison of these CASI results between groups, since the comparison is not based on all

randomized patients but rather is conditional on the survival of subjects at 90 days or 1 year.

239 (28.4)

Subjects with a Drug/Medication Overdose

199 (23.8)

A post-hoc analysis of subjects with a presumed medication or drug overdose, as determined by

CEC adjudication, suggested that CPR using the ResQCPR System in this patient population may

have resulted in unfavorable clinical results for drug/medication overdose patients as compared to

105 (12.5)

both 1) S-CPR for drug/medication overdose patients, and 2) CPR utilizing the ResQCPR System

735

for non-traumatic arrest patients not having drug/medication overdose as the arrest etiology.

Among S-CPR and ResQCPR subjects with drug/medication overdose arrest etiologies, 20% of

96 (11.5)

S-CPR (13/65) and 14% of ResQCPR (14/97) subjects survived to hospital discharge.

741

Overall Conclusions

87 (10.4)

The results of the pivotal trial demonstrate that the ResQCPR System increased the likelihood of

746

survival after non-traumatic out-of-hospital cardiac arrest when compared with manual S-CPR, the

current standard of care for treatment of out-of-hospital cardiac arrest in the United States today.

74 (9.0)

One year survival rates were relatively 34% higher when CPR was performed with the ResQCPR

748

System compared with S-CPR for all subjects in the ITT population (7.8% vs. 5.8%), and relatively

49% higher for those in the mITT population (9.0% vs. 6.0%). These principal data elements that

led to device approval by FDA, and are accordingly represented in the labeling and indications

for use for the ResQCPR System, were a post hoc analysis of survival not incorporating the

consideration of neurological function. One year after OHCA, more than 95% of surviving

subjects in both treatment groups had excellent neurological function, as determined by cognitive,

functional, and quality of life testing. In cardiac arrest of etiology known to be drug/medication

overdose, the favorable results with use of the ResQCPR System may not be present.

RESQPOD ITD 16 TECHNICAL SPECIFICATIONS

Operating Specifications

Safety check valve threshold

Expiratory airway impedance

Timing assist lights flash rate

Shelf Life

Temperature Range

Operation

Storage

Dimensions

Height

Diameter

Circumference

Patient side connection

Ventilation side connection

Dead space

Weight

Materials

Exterior housing and interior molded components

Diaphragm and safety check valve gasket

Safety check valve spring

Battery

RESQPUMP ACD-CPR DEVICE TECHNICAL SPECIFICATIONS

Operating Specifications

mITT

Force gauge compression range

ResQCPR

S-CPR

ResQCPR

Force gauge decompression range

(n= 1269)

(n=813)

(n=842)

Metronome Function

1194 (94.1)

766 (94.2)

789 (93.7)

Signal pitches

Sound level

1115 (87.9)

729 (89.7)

735 (87.3)

Rate

260 (20.5)

161 (19.8)

185 (22.0)

Temperature Range

11 (0.9)

3 (0.4)

2 (0.2)

0 (0.0)

1 (0.1)

Operation

3 (0.2)

1(0.1)

2 (0.2)

Storage

17 (1.3)

3 (0.4)

7 (0.8)

Dimensions

5 (0.4)

3 (0.4)

2 (0.2)

Suction cup

16 (1.3)

7 (0.9)

8 (1.0)

Height

13 (1.0)

7 (0.9)

10 (1.2)

Weight

23 (1.8)

13 (1.6)

11 (1.3)

Materials

18 (1.4)

14 (1.7)

11 (1.3)

143 (11.3)

62 (7.6)

94 (11.2)

Suction cup and cushion pad

Handle and support ring

Connection stem

Support ring

Metal parts

Battery

ResQPOD and ResQPUMP are registered trademarks of Advanced Circulatory. These products and

their use are protected by one or more of the following patents: USA – 5,645,522; 6,155,257;

6,224,562; 6,234,985; 6,312,399; 6,425,393; 6,463,327; 6,587,726; 8,151,790.

Foreign – CNZL96193712.2; EP0898485 (France, Germany, Italy, Sweden, United Kingdom).

Other USA and country patents pending.

ACCESSORIES AND REPLACEMENT COMPONENTS AVAILABLE

FOR THE RESQCPR SYSTEM

Reorder #

Description

12-0825-000

ResQCPR System (one ResQPUMP; two ResQPODs)

12-0822-000

ResQPOD ITD 16 (single device)

12-0823-000

ResQPUMP ACD-CPR Device (single device)

12-0586-000

Suction Cup for ACD-CPR Device (replacement suction

cup with support ring and compression cushion)

12-0935-000

ResQCPR Carrying Case (holds one ResQPUMP and two ResQPODs)

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