Sham Impedance Threshold Device Research Articles

Correlation of Impedance Threshold Device use during cardiopulmonary resuscitation with post-cardiac arrest Acute Kidney Injury

PurposeTo assess whether use of Impedance Threshold Device (ITD) during cardiopulmonary resuscitation (CPR) reduces the degree of post-cardiac arrest Acute Kidney Injury (AKI), as a result of improved hemodynamics, in a porcine model of ventricular fibrillation (VF) cardiac arrest. MethodsAfter 8 min of untreated cardiac arrest, the animals were resuscitated either with active compression-decompression (ACD) CPR plus a sham ITD (control group, n=8) or with ACD-CPR plus an active ITD (ITD group, n=8). Adrenaline was administered every 4 min and electrical defibrillation was attempted every 2 min until return of spontaneous circulation (ROSC) or asystole. After ROSC the animals were monitored for 6 h under general anesthesia and then returned to their cages for a 48 h observation, before euthanasia. Two novel biomarkers, Neutrophil Gelatinase-Associated Lipocalin (NGAL) in plasma and Interleukin-18 (IL-18) in urine, were measured at 2 h, 4 h, 6 h, 24 h and 48 h post-ROSC, in order to assess the degree of AKI. ResultsROSC was observed in 7 (87.5%) animals treated with the sham valve and 8 (100%) animals treated with the active valve (P=NS). However, more than twice as many animals survived at 48 h in the ITD group (n=8, 100%) compared to the control group (n=3, 37.5%). Urine IL-18 and plasma NGAL levels were augmented post-ROSC in both groups, but they were significantly higher in the control group compared with the ITD group, at all measured time points. ConclusionUse of ITD during ACD-CPR improved hemodynamic parameters, increased 48 h survival and decreased the degree of post-cardiac arrest AKI in the resuscitated animals.

Impedance Threshold Device Combined With High-Quality Cardiopulmonary Resuscitation Improves Survival With Favorable Neurological Function After Witnessed Out-of-Hospital Cardiac Arrest

The quality of cardiopulmonary resuscitation (CPR) has been recently shown to affect clinical outcome. The Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Impedance Valve and Early Versus Delayed Analysis (PRIMED) trial showed no differences in outcomes with an active vs. sham impedance threshold device (ITD), a CPR adjunct that enhances circulation. It was hypothesized the active ITD would improve survival with favorable neurological outcomes in witnessed out-of-hospital cardiac arrest patients when used with high-quality CPR. Using the publicly accessible ROC PRIMED database, a post-hoc analysis was performed on all witnessed subjects with both compression rate and depth data (n=1,808) who received CPR within the study protocol definition of adequate CPR quality (compression rate 80-120/min and depth 4-6 cm; n=929). Demographics were similar between sham and active ITD groups. In witnessed subjects who received quality CPR, survival with favorable neurological function was 11.9% for the active ITD subjects (56/470) vs. 7.4% for the sham (34/459) (odds ratio 1.69 [95% confidence interval 1.08, 2.64]). There were no statistically significant differences for this primary outcome when CPR was performed outside the boundaries of the definition of adequate CPR quality. Multivariable models did not change these associations. An active ITD combined with adequate-quality conventional CPR has the potential to significantly improve survival after witnessed cardiac arrest. (Circ J 2016; 80: 2124-2132).

Hemodynamic improvement of a LUCAS 2 automated device by addition of an impedance threshold device in a pig model of cardiac arrest

IntroductionThe combination of the LUCAS 2 (L-CPR) automated CPR device and an impedance threshold device (ITD) has been widely implemented in the clinical field. This animal study tested the hypothesis that the addition of an ITD on L-CPR would enhance cerebral and coronary perfusion pressures. MethodsTen female pigs (39.0±2.0kg) were sedated, intubated, anesthetized with isofluorane, and paralyzed with succinylcholine (93.3μg/kg/min) to inhibit the potential confounding effect of gasping. After 4min of untreated ventricular fibrillation, 4min of L-CPR+an active ITD or L-CPR+a sham ITD was initiated and followed by another 4min of the alternative method of CPR. Systolic blood pressure (SBP), diastolic blood pressure (DBP), diastolic right atrial pressure (RAP), intracranial pressure (ICP), airway pressure, and end tidal CO2 (ETCO2) were recorded continuously. Data expressed as mean mmHg±SD. ResultsDecompression phase airway pressure was significantly lower with L-CPR+active ITD versus L-CPR+sham ITD (−5.3±2.2 vs. −0.5±0.6; p<0.001). L-CPR+active ITD treatment resulted in significantly improved hemodynamics versus L-CPR+sham ITD: ETCO2, 35±6 vs. 29±7 (p=0.015); SBP, 99±9 vs. 93±15 (p=0.050); DBP, 24±12 vs. 19±15 (p=0.006); coronary perfusion pressure, 29±8 vs. 26±7 (p=0.004) and cerebral perfusion pressure, 24±13 vs. 21±12 (p=0.028). ConclusionsIn pigs undergoing L-CPR the addition of the active ITD significantly reduced intrathoracic pressure and increased vital organ perfusion pressures.

Respiratory pump contributes to increased physiological reserve for compensation during reductions in central blood volume (707.4)

The impedance threshold device (ITD) represents a therapy for increasing systemic circulation through creation of negative intrathoracic pressure. PURPOSE: To evaluate the respiratory pump effect on the diminution of compensatory responses during progressive reductions in central blood volume. METHODS: The Compensatory Reserve Index (CRI) algorithm measured compensation capacity to reduced central blood volume. Continuous analog recordings of arterial waveforms were extracted from data files of 7 volunteers. Subjects had previously participated in experiments designed to induce hemodynamic decompensation by application of graded lower body negative pressure (LBNP). The LBNP protocol was completed while spontaneously breathing through a standard medical facemask without (sham ITD) and with (active ITD) a resistance (~‐7cmH2O). RESULTS: At the onset of pre‐syncope in the sham ITD, CRI (0.08±0.02) was smaller (P=0.05) than CRI at the same time point in the active ITD (0.09±0.01). CRI at pre‐syncope in the active ITD (0.08±0.01) was similar (P=0.19) to CRI at pre‐syncope in the sham ITD. Kaplan‐Meier and log rank tests indicated that CRI survival curves shifted to the right (P=0.04) by the active ITD. CONCLUSIONS: Optimizing the respiratory pump contributed a small but significant effect of increasing tolerance to progressive reductions in central blood volume by extending the compensatory reserve.Grant Funding Source: U.S. Army MRMC Combat Casualty Care Research Program

Use of the impedance threshold device improves survival rate and neurological outcome in a swine model of asphyxial cardiac arrest*

To assess whether intermittent impedance of inspiratory gas exchange improves hemodynamic parameters, 48-hr survival, and neurologic outcome in a swine model of asphyxial cardiac arrest treated with active compression-decompression cardiopulmonary resuscitation. Prospective, randomized, double-blind study. Laboratory investigation. Thirty healthy Landrace/Large-White piglets of both sexes, aged 10 to 15 wks, whose average weight was 19 ± 2 kg. At approximately 7 mins following endotracheal tube clamping, ventricular fibrillation was induced and remained untreated for another 8 mins. Before initiation of cardiopulmonary resuscitation, animals were randomly assigned to either receive active compression-decompression cardiopulmonary resuscitation plus a sham impedance threshold device (control group, n = 15), or active compression-decompression cardiopulmonary resuscitation plus an active impedance threshold device (experimental group, n = 15). Electrical defibrillation was attempted every 2 mins until return of spontaneous circulation or asystole. Return of spontaneous circulation was observed in six (40%) animals treated with the sham valve and 14 (93.3%) animals treated with the active valve (p = .005, odds ratio 21.0, 95% confidence interval 2.16-204.6). Neuron-specific enolase and S-100 levels increased in the ensuing 4 hrs post resuscitation in both groups, but they were significantly elevated in animals treated with the sham valve (p < .01). At 48 hrs, neurologic alertness score was significantly better in animals treated with the active valve (79.1 ± 18.7 vs. 50 ± 10, p < .05) and was strongly negatively correlated with 1- and 4-hr postresuscitation neuron-specific enolase (r = -.86, p < .001 and r = -.87, p < .001, respectively) and S-100 (r = -.77, p < .001 and r = -0.8, p = .001) values. In this model of asphyxial cardiac arrest, intermittent airway occlusion with the impedance threshold device during the decompression phase of active compression-decompression cardiopulmonary resuscitation significantly improved hemodynamic parameters, 24- and 48-hr survival, and neurologic outcome evaluated both with clinical and biochemical parameters (neuron-specific enolase, S-100).

Early versus Later Rhythm Analysis in Patients with Out-of-hospital Cardiac Arrest: Stiell IG, Nichol G, Leroux BG, et al. N Engl J Med 2011;265:787–97.

This study compared the strategy of a brief period of cardiopulmonary resuscitation (CPR) with early analysis of rhythm and delivery of indicated defibrillatory shocks as soon as possible with the strategy of a longer period of CPR with a delayed analysis of rhythm. The study was a cluster-randomized trial comprising 10 United States and Canadian universities and their regional emergency medical service (EMS) systems. Most patients were enrolled simultaneously in the study described herein as well as a concurrent study comparing the use of an impedance threshold device (ITD) with use of a sham ITD.

A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest

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. 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). 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. 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.).

Inspiratory resistance, cerebral blood flow velocity, and symptoms of acute hypotension

INTRODUCTION Symptoms of orthostatic intolerance, e.g., following prolonged bed rest and microgravity exposure, are associated with reductions in cerebral blood flow. We tested the hypothesis that spontaneously breathing through an impedance threshold device (ITD) would attenuate the fall in cerebral blood flow velocity (CBFV) during a hypotensive orthostatic challenge and reduce the severity of reported symptoms. METHODS While breathing through either an active ITD (-7 cm H2O inspiratory impedance) or a sham ITD (no impedance), 19 subjects performed a squat stand test (SST). Symptoms upon stand were recorded on a 5-point scale (1 = normal; 5 = faint) of subject-perceived rating (SPR). To address our hypothesis, only data from symptomatic subjects (SPR > 1 during the sham trial) were analyzed (N = 9). Mean arterial blood pressure (MAP) and mean CBFV were measured continuously throughout the SST and analyzed in time and frequency domains. RESULTS Breathing with the active ITD during the SST reduced the severity of orthostatic symptoms in eight of the nine symptomatic subjects (sham ITD SPR, 1.9 +/- 0.1; active ITD SPR, 1.1 +/- 0.1), but there was no statistically distinguishable difference in the reduction of mean CBFV between the two trials (sham ITD, -39 +/- 3% vs. active ITD, -44 +/- 3%). High frequency oscillations in mean CBFV, however, were greater during the active ITD trial (7.8 +/- 2.6 cm x s(-2)) compared with the sham ITD trial (2.5 +/- 0.9 cm x s(-2)). CONCLUSIONS Higher oscillations in CBFV while breathing with the active ITD may account for the reduction in symptom severity during orthostatic hypotension despite the same fall in absolute CBFV.

Abstract P22: An Impedance Threshold Device Combined with an Automated Active Compression Decompression CPR Device (LUCAS) Improves the Chances For Survival in Pigs in Cardiac Arrest

Background: By lowering intrathoracic pressure during the chest recoil phase of CPR, the impedance threshold device (ITD) increases circulation and the rate of return of spontaneous circulation (ROSC). This study evaluated the ITD combined with a new automated CPR device, the US version of the LUCAS, that compresses the chest and then pulls upwards with a 3 lb force. Methods and Results: After 6 min of untreated ventricular fibrillation, anesthetized female pigs (40.0±0.7 kg) were randomized to 6 min of CPR (100 compressions/min with LUCAS and ventilation: 1.0 FiO2, tidal volume of 10ml/kg, rate 12/min) with an active (−10 cm H2O resistance) (n=12) or sham ITD (n=12), and then shocked once with 120 joules of direct current. Epinephrine (0.04 mg/kg) and more CPR and shocks were used if ROSC was not achieved. Results (in mmHg) after 6 min of CPR with an active vs. sham ITD were: coronary perfusion pressure (PP) 20.8±1.2 vs. 21.0±0.9 (p=0.94); cerebral PP 8.8±1.0 vs. 10.0±0.9 (p=0.62); and end tidal CO2 38.1±1.5 and 37.1±1.3 (p=0.61). Peak and mean carotid artery blood flow (ml/min) was 323.9±15.2 vs. 256.6±21.1 (p=0.17) and 95.3±5.4 vs. 77.0±6.0 (p=0.22) with an active vs. sham ITD, respectively. Mean endotracheal pressures (mmHg) during chest recoil with an active vs. sham ITD were −2.0±0.5 vs. −0.2±0.2 (p&lt;0.01). Arterial and venous blood gases were similar after 6 min of CPR between groups. ROSC, the primary survival endpoint for comparing the active vs. sham ITD, was 7/12 vs. 2/12 after 1 shock (p= 0.09), 12/12 vs. 5/12 after 2 shocks (p&lt;0.01), and 12/12 vs. 7/12 after 3 shocks (p=0.04). With up to 14 shocks, 10/12 sham animals had a ROSC. All animals with ROSC lived for 30 min. There was no evidence of pulmonary edema or organ damage on autopsy with either ITD. Conclusions: After 6 min of CPR, LUCAS and active ITD resulted in lower mean airway pressures during chest recoil versus controls but hemodynamic findings were similar. However, ROSC was significantly easier to achieve with an active ITD; with up to 3 shocks twice as many animals were resuscitated with an active ITD. This benefit is most likely explained by carotid blood flows that trended higher with the active ITD. These positive findings and lack of any adverse outcomes support the safety and efficacy of this device combination.

Inspiratory Resistance, Cerebral Blood Flow Velocity, and Symptoms of Acute Hypotension

Symptoms of orthostatic intolerance, e.g., following prolonged bed rest and microgravity exposure, are associated with reductions in cerebral blood flow. We tested the hypothesis that spontaneously breathing through an impedance threshold device (ITD) would attenuate the fall in cerebral blood flow velocity (CBFV) during a hypotensive orthostatic challenge and reduce the severity of reported symptoms. While breathing through either an active ITD (-7 cm H2O inspiratory impedance) or a sham ITD (no impedance), 19 subjects performed a squat stand test (SST). Symptoms upon stand were recorded on a 5-point scale (1 = normal; 5 = faint) of subject-perceived rating (SPR). To address our hypothesis, only data from symptomatic subjects (SPR > 1 during the sham trial) were analyzed (N = 9). Mean arterial blood pressure (MAP) and mean CBFV were measured continuously throughout the SST and analyzed in time and frequency domains. Breathing with the active ITD during the SST reduced the severity of orthostatic symptoms in eight of the nine symptomatic subjects (sham ITD SPR, 1.9 +/- 0.1; active ITD SPR, 1.1 +/- 0.1), but there was no statistically distinguishable difference in the reduction of mean CBFV between the two trials (sham ITD, -39 +/- 3% vs. active ITD, -44 +/- 3%). High frequency oscillations in mean CBFV, however, were greater during the active ITD trial (7.8 +/- 2.6 cm x s(-2)) compared with the sham ITD trial (2.5 +/- 0.9 cm x s(-2)). Higher oscillations in CBFV while breathing with the active ITD may account for the reduction in symptom severity during orthostatic hypotension despite the same fall in absolute CBFV.

Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods: Part 1: Rationale and methodology for the impedance threshold device (ITD) protocol

The primary aim of this study is to compare survival to hospital discharge with a modified Rankin score (MRS)< or =3 between standard cardiopulmonary resuscitation (CPR) plus an active impedance threshold device (ITD) versus standard CPR plus a sham ITD in patients with out-of-hospital cardiac arrest. Secondary aims are to compare functional status and depression at discharge and at 3 and 6 months post-discharge in survivors. Prospective, double-blind, randomized, controlled, clinical trial. Patients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers. EMS systems participating in the Resuscitation Outcomes Consortium. Based on a one-sided significance level of 0.025, power=0.90, a survival with MRS< or =3 to discharge rate of 5.33% with standard CPR and sham ITD, and two interim analyses, a maximum of 14,742 evaluable patients are needed to detect a 6.69% survival with MRS< or =3 to discharge with standard CPR and active ITD (1.36% absolute survival difference). If the ITD demonstrates the hypothesized improvement in survival, it is estimated that 2700 deaths from cardiac arrest per year would be averted in North America alone.

Blood Pressure Response to the ImpedanceThreshold Device in Hypotensive Emergency Department Patients

Background: An impedance threshold device (ITD) has been found to enhance circulation during CPR by increasing cardiac preload. Additionally, in the spontaneously breathing patient, the ITD has been found to create a small degree of inspiratory resistance (‐6 cm H2O at flow rate of 20L/min). Hypothesis: We sought to determine the effects of the ITD on awake patients with hypotension presenting to the emergency department. We hypothesized that the ITD would improve blood pressure when compared to standard therapy. The main outcome measure was the systolic blood pressure (SBP) change during 10 minutes of ITD use.Methods: A convenience sample of patients with SBPs &lt;95 mmHg were randomized in double‐blind fashion to active or sham ITDs. Patients were enrolled if they were between the ages of 18 and 70 and their hypotension was felt to be due to non‐traumatic blood loss or dehydration by the treating physician. Patients were excluded if they were experiencing shortness of breath, chest pain, failed the abbreviated mini‐mental status exam, or had predefined cardiac/pulmonary history criteria. After consent and baseline measurements, patients spontaneously breathed through a mouthpiece attached to an active or sham ITD for a 10 minute period during which vital signs and patient status were recorded.Results: 12 patients were enrolled (5 randomized to the active device, 7 to the sham device). Mean baseline SBPs were similar between groups with the active and sham devices having baseline SBPs of 84.5 mmHg (SD 5.45) and 83.67 mmHg (SD 10.02), respectively. The active ITD produced a statistically significant (p = 0.03) increase in SBP of 13.0 mmHg (SD 4.69) compared to the sham ITD, 2.33 mmHg (SD 0.58).Conclusions: In spontaneously breathing hypotensive ED patients, the ITD was well‐tolerated and increased the SBP. If these results are validated with a larger sample, the ITD may be a useful adjunct in the treatment of hypotension due to volume loss in the ED.

Breathing through an inspiratory threshold device improves stroke volume during central hypovolemia in humans

Inspiratory resistance induced by breathing through an impedance threshold device (ITD) reduces intrathoracic pressure and increases stroke volume (SV) in supine normovolemic humans. We hypothesized that breathing through an ITD would also be associated with a protection of SV and a subsequent increase in the tolerance to progressive central hypovolemia. Eight volunteers (5 men, 3 women) were instrumented to record ECG and beat-by-beat arterial pressure and SV (Finometer). Tolerance to progressive lower body negative pressure (LBNP) was assessed while subjects breathed against either 0 (sham ITD) or -7 cmH(2)O inspiratory resistance (active ITD); experiments were performed on separate days. Because the active ITD increased LBNP tolerance time from 2,014 +/- 106 to 2,259 +/- 138 s (P = 0.006), data were analyzed (time and frequency domains) under both conditions at the time at which cardiovascular collapse occurred during the sham experiment to determine the mechanisms underlying this protective effect. At this time point, arterial blood pressure, SV, and cardiac output were higher (P < or = 0.005) when breathing on the active ITD rather than the sham ITD, whereas indirect indicators of autonomic activity (low- and high-frequency oscillations of the R-to-R interval) were not altered. ITD breathing did not alter the transfer function between systolic arterial pressure and R-to-R interval, indicating that integrated baroreflex sensitivity was similar between the two conditions. These data show that breathing against inspiratory resistance increases tolerance to progressive central hypovolemia by better maintaining SV, cardiac output, and arterial blood pressures via primarily mechanical rather than neural mechanisms.

Abstract 2840: An Impedance Threshold Device Improves 24 Hour Survival in a Spontaneously Breathing Pediatric Porcine Model of Hemorrhagic Shock

Introduction: Traumatic injury and hypovolemic shock are leading causes of death in children worldwide. We previously demonstrated that augmentation of negative intrathoracic pressure generated by spontaneously breathing through an impedance threshold device (ITD) improves blood pressure and cardiac output in a pediatric porcine model of hemorrhagic shock. However, the optimal method to restore intravascular volume, prevent secondary organ damage, and prevent progression of reversible shock to irreversible circulatory collapse after severe blood loss in children is not known. Hypothesis: Breathing through an ITD for 90 min prior to fluid resuscitation will safely increase short and long-term survival rates. Methods: Seventeen spontaneously breathing female piglets (12.4 ± 0.1 kg), anesthetized with propofol, were subjected to a 40% bleed and randomized in a prospective, blinded manner to either a sham or active ITD (cracking pressure of -7 cmH2O, Advanced Circulatory Systems, Minneapolis, MN) for 90 min. Shed blood was then reinfused. Work of breathing (WOB), 90 minute and 24 hour survival were evaluated. Survival analysis was performed using the Wilcoxon Rank Sum Test, Fischer’s Exact Test, and Kaplan-Meier Methods. Results: Baseline and post-bleed heart rate, blood pressure, lactate levels, and arterial blood gas parameters were similar between groups. Piglets treated with the active ITD had significantly improved survival compared to the piglets treated with the sham ITD at 90 min (8/9 vs. 3/8, p=0.04). At 24 hours, Kaplan-Meier curve analysis revealed improved survival with the active ITD (6/9 vs. 2/8, p=0.04). The 3 animals in the active ITD group that did not survive died at a median time of 280 minutes (82–580), and the 6 animals in the sham group that did not survive, died at a median time of 69 minutes (24 –101) after bleed (p=0.11). The WOB at 45 min (J/L) was 73% higher in the active ITD group than the sham group (1.18 ± 0.07 vs. 0.68 ± 0.07, p= 0.001). The piglets safely tolerated the active ITD therapy. Conclusion: In this spontaneously breathing, anesthetized piglet model of hemorrhagic shock, treatment with an active ITD for 90 min without supplemental fluid resuscitation significantly improved short and long-term survival rates.

Abstract 2002: Dual Mechanism of Blood Flow Augmentation to the Brain using an Impedance Threshold Device in a Pediatric Model of Cardiac Arrest

Background: During cardiac arrest use of an impedance threshold device (ITD) increases circulation and the chances for survival. The ITD has not been systematically evaluated during conventional CPR in a pediatric animal model. We hypothesized that the ITD increases blood flow to the brain by lowering intrathoracic pressure during the CPR decompression phase thus enhancing venous return to the right heart and forward flow with the subsequent compression and maintaining or lowering diastolic intracranial pressure (ICP) thus reducing resistance to forward flow. In this manner ITD use was hypothesized to mimic the ‘gasping reflex’ during CPR. Methods: In the first study 9 female propofol anesthetized piglets (10–12 kg) were subjected to 6 min of untreated ventricular fibrillation, 6 min of conventional CPR (ventilation rate 10 bpm), then 6 min of CPR with an active ITD (resistance of −10 cm H20). A second study was similar except that a sham ITD was used in 8 piglets. Results: After 2 min of active ITD treatment, decompression phase airway pressures (surrogate for intrathoracic pressure) (mmHg) decreased from −0.5 ± 0.2 to −2.6 ± 0.5 (mean ± SEM, p &lt; 0.001) and common carotid blood flow (mL/min) increased by 65% (59.2 ± 16.7 to 91.1± 27.9, p = 0.02). In the sham group, airway pressures were unchanged and carotid blood flow decreased from 39 ± 2.5 to 38.8 ± 4.3 (p = 0.47). ICP decreased more rapidly in time and to a greater degree in 6/9 piglets when comparing ITD use to measurements preceding its application, contributing to an increase in cerebral perfusion (CePP) (mmHg) in 5/9 active ITD piglets, while in the sham group, CePPs remained the same or decreased in 8/8 piglets (p = 0.03). Coronary perfusion pressures (CPP) (mmHg) increased in 5/9 piglets after 2 min of the active ITD and remained the same or decreased in 8/8 piglets treated with the sham device (p = 0.03). Return of spontaneous circulation was achieved with a single shock in 4/9 active ITD piglets and 1/8 sham ITD piglets (p = 0.29). Conclusions: Use of an active ITD during CPR in piglets significantly increased carotid blood flow and CPPs. The ITD also lowered ICP during the decompression phase, similar to the mechanism of the ‘last gasp’, thereby reducing resistance to forward blood flow to the brain.

Inspiratory resistance maintains arterial pressure during central hypovolemia: Implications for treatment of patients with severe hemorrhage

To test the hypothesis that an impedance threshold device would increase systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure and delay the onset of symptoms and cardiovascular collapse associated with severe central hypovolemia. Prospective, randomized, blinded trial design. Human physiology laboratory. Nine healthy nonsmoking normotensive subjects (five males, four females). Central hypovolemia and impending cardiovascular collapse were induced in human volunteers by applying progressive lower body negative pressure (under two experimental conditions: a) while breathing with an impedance threshold device set to open at -7 cm H2O pressure (active impedance threshold device); and b) breathing through a sham impedance threshold device (control). Systolic blood pressure (79 +/- 5 mm Hg), diastolic blood pressure (57 +/- 3 mm Hg), and mean arterial pressure (65 +/- 4 mm Hg) were lower (p < .02) when subjects (n = 9) breathed through the sham impedance threshold device than when they breathed through the active impedance threshold device at the same time of cardiovascular collapse during sham breathing (102 +/- 3, 77 +/- 3, 87 +/- 3 mm Hg, respectively). Elevated blood pressure was associated with 23% greater lower body negative pressure tolerance using an active impedance threshold device (1639 +/- 220 mm Hg-min) compared with a sham impedance threshold device (1328 +/- 144 mm Hg-min) (p = .02). Use of an impedance threshold device increased systemic blood pressure and delayed the onset of cardiovascular collapse during severe hypovolemic hypotension in spontaneously breathing human volunteers. This device may provide rapid noninvasive hemodynamic support in patients with hypovolemic hypotension once the blood loss has been controlled but before other definitive therapies are available.

Increased impedance to inspiration ameliorates hemodynamic changes associated with movement to upright posture in orthostatic hypotension: A randomized blinded pilot study

Movement to upright posture may result in marked drop of blood pressure with susceptibility to injury from syncope and falls in patients with orthostatic hypotension. The purpose of this study was to determine if increasing negative intrathoracic pressure by using an inspiratory impedance threshold device before change of posture diminishes blood pressure fall by enhancing venous return. Eighteen healthy subjects and 22 orthostatic hypotension patients were randomized to either an active (impedance 7 cmH2O) or sham (no inspiratory impedance) impedance threshold device. Arterial blood pressure, heart rate, and estimated stroke volume and total peripheral resistance were recorded in the supine and upright postures using a noninvasive finger arterial blood pressure monitor. After a rest period, the alternate impedance threshold device (sham or active) was tested in each individual. Compared with the sham impedance threshold device test, the active impedance threshold device resulted in significant reduction in the magnitude of upright posture-induced fall in blood pressure and a greater increase of total peripheral resistance after standing in both healthy subjects and orthostatic hypotension patients. Stroke volume was not measurably altered. Among all subjects who exhibited a postural blood pressure drop >10 mmHg on the day of study, active impedance threshold device treatment consistently blunted blood pressure fall during the initial 100 seconds after standing (<0.04). Induced orthostatic symptoms were less severe with the active impedance threshold device both at onset of upright posture and during 30 seconds of standing. Enhancing impedance to inspiration may prove useful as adjunctive therapy for diminishing symptoms associated with movement to upright posture in individuals with orthostatic hypotension.

Clinical evaluation of an inspiratory impedance threshold device during standard cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest*

To determine whether an impedance threshold device, designed to enhance circulation, would increase acute resuscitation rates for patients in cardiac arrest receiving conventional manual cardiopulmonary resuscitation. Prospective, randomized, double-blind, intention-to-treat. Out-of-hospital trial conducted in the Milwaukee, WI, emergency medical services system. Adults in cardiac arrest of presumed cardiac etiology. On arrival of advanced life support, patients were treated with standard cardiopulmonary resuscitation combined with either an active or a sham impedance threshold device. We measured safety and efficacy of the impedance threshold device; the primary end point was intensive care unit admission. Statistical analyses performed included the chi-square test and multivariate regression analysis. One hundred sixteen patients were treated with a sham impedance threshold device, and 114 patients were treated with an active impedance threshold device. Overall intensive care unit admission rates were 17% with the sham device vs. 25% in the active impedance threshold device (p = .13; odds ratio, 1.64; 95% confidence interval, 0.87, 3.10). Patients in the subgroup presenting with pulseless electrical activity had intensive care unit admission and 24-hr survival rates of 20% and 12% in sham (n = 25) vs. 52% and 30% in active impedance threshold device groups (n = 27) (p = .018, odds ratio, 4.31; 95% confidence interval, 1.28, 14.5, and p = .12, odds ratio, 3.09; 95% confidence interval, 0.74, 13.0, respectively). A post hoc analysis of patients with pulseless electrical activity at any time during the cardiac arrest revealed that intensive care unit and 24-hr survival rates were 20% and 11% in the sham (n = 56) vs. 41% and 27% in the active impedance threshold device groups (n = 49) (p = .018, odds ratio, 2.82; 95% confidence interval, 1.19, 6.67, and p = .037, odds ratio, 3.01; 95% confidence interval, 1.07, 8.96, respectively). There were no statistically significant differences in outcomes for patients presenting in ventricular fibrillation and asystole. Adverse event and complication rates were also similar. During this first clinical trial of the impedance threshold device during standard cardiopulmonary resuscitation, use of the new device more than doubled short-term survival rates in patients presenting with pulseless electrical activity. A larger clinical trial is underway to determine the potential longer term benefits of the impedance threshold device in cardiac arrest.

Hemodynamics associated with breathing through an inspiratory impedance threshold device in human volunteers

Increased negative intrathoracic pressure during spontaneous inspiration through an impedance threshold device (ITD) causes elevated arterial blood pressure in humans. This study was performed to determine whether the acute increase in blood pressure induced by breathing through an ITD is associated with increased stroke volume and cardiac output. Randomized, blinded, controlled trial. Laboratory. Ten women and ten men. We measured hemodynamic and respiratory responses during two separate ITD conditions: 1) breathing through a face mask with an ITD (impedance of 6 cm H2O [0.59 kPa]) and 2) breathing through the same face mask with a sham ITD (control). Stroke volume was measured by thoracic bioimpedance. Compared with the control condition, ITD produced higher stroke volume (124 +/- 3 vs. 137 +/- 3 mL; p = .013), heart rate (63 +/- 3 vs. 68 +/- 3 beats/min; p = .049), cardiac output (7.69 vs. 9.34 L/min; p = .001), and systolic blood pressure (115 +/- 2 to 122 +/- 2 mm Hg [15.33 +/- 0.3 to 16.26 +/- 0.3 kPa]; p = .005) without affecting expired minute ventilation (6.2 +/- 0.4 to 6.5 +/- 0.4 L/min; p = .609). Breathing with an ITD at relatively low impedance increases systolic blood pressure by increasing stroke volume and cardiac output. The ITD may provide short-term protection against cardiovascular collapse induced by orthostatic stress or hemorrhage.

Combination of active compression decompression cardiopulmonary resuscitation and the inspiratory impedance threshold device: state of the art.

Over the past decade, the combination of active compression decompression (ACD) cardiopulmonary resuscitation (CPR) and an impedance threshold device (ITD) has been shown to significantly increase vital organ perfusion pressures and survival rates in animals and humans. The purpose of this review article is to summarize the recent advances with this new technology. Building upon animal studies that demonstrated the benefit of the ITD used with either ACD CPR or standard CPR (S-CPR), four prospective, randomized clinical trials with ACD/ITD CPR have been recently completed. One blinded, out-of-hospital cardiac arrest trial (n = 21 patients) demonstrated that systemic blood pressures and coronary perfusion pressures were markedly higher when ACD/ITD CPR was used when compared directly with ACD CPR alone. The second blinded trial demonstrated that the combination of ACD/ITD CPR was effective with both a facemask and an endotracheal tube (n = 15 patients). A third randomized clinical trial (n = 210 patients) demonstrated that 24-hour survival rates for out-of-hospital cardiac arrest were more than 65% higher with ACD/ITD CPR than with S-CPR (P < 0.01). Neurologic function after cardiac arrest trended higher in patients with witnessed arrest who received ACD/ITD CPR than in those who received S-CPR(P < 0.07). In addition, when ACD/ITD CPR was applied later in the course of treatment, short-term survival rates were threefold higher in patients receiving ACD/ITD CPR (44%) than in those receiving S-CPR (14%)(P < 0.05). In that study, patients with the greatest chance for survival-those with witnessed cardiac arrest and an initial rhythm of ventricular fibrillation-had a 23% 24-hour survival rate with S-CPR versus a 58% 24-hour survival rate with ACD/ITD CPR (P < 0.01). It should be noted that this trial was performed in a city where an earlier study found no difference in outcomes between ACD CPR alone and S-CPR. The fourth clinical trial was a randomized, double-blinded study of 400 patients with out-of-hospital cardiac arrest treated by advanced life support personnel. All patients received ACD CPR: half were treated with a sham ITD and the other half were treated with an active ITD. Twenty-four hour survival, the primary endpoint, was 32% in the active ITD group versus 22% in the sham group (P < 0.05). On the basis of the cumulative findings of these studies, it is concluded that ACD/ITD CPR provides superior vital organ blood flow and results in significantly higher short-term survival rates than do ACD CPR alone or S-CPR. Use of the ACD/ITD CPR technology optimizes perfusion of the heart and brain during cardiac arrest and results in the highest reported survival rates of any CPR device technology. Use of this technology should be encouraged while additional studies are under way to examine the potential long-term impact of this new technology.