An impedance threshold device increases blood pressure in hypotensive patients.

BACKGROUND: The impedance threshold device (ITD-7) augments the vacuum created in the thorax with each inspiration, thereby enhancing blood flow from the extrathoracic venous systems into the heart. OBJECTIVES: To the best of our knowledge, the ITD-7 has not previously been investigated in hypotensive patients in the emergency department (ED) or the prehospital setting. The objective of this study was to determine whether the ITD-7 would increase systolic arterial pressures in hypotensive spontaneously breathing patients. METHODS: The ED study was a prospective, randomized, double-blind, sham control design. Patients with a systolic blood pressure ≤ 95 mm Hg were randomized to breathe for 10 min through an active or sham ITD. The primary endpoint was the change in systolic blood pressure measured non-invasively. The prehospital study was a prospective, non-blinded evaluation of the ITD-7 in hypotensive patients. RESULTS: In the ED study, the mean ± standard deviation rise in systolic blood pressure was 12.9 ± 8.5 mm Hg for patients (n = 16) treated with an active ITD-7 vs. 5.9 ± 5.9 mm Hg for patients (n = 18) treated with a sham ITD-7 (p < 0.01). In the prehospital study, the mean systolic blood pressure before the ITD-7 was 79.4 ± 10.2 mm Hg and 107.3 ± 17.6 mm Hg during ITD-7 use (n = 47 patients) (p < 0.01). CONCLUSION: During this clinical evaluation of the ITD-7 for the treatment of hypotensive patients in the ED and in the prehospital setting, use of the device significantly increased systolic blood pressure and was safe and generally well tolerated.

Long-term implementation of a prehospital severity scale for EMS triage of acute stroke: a real-world experience.

BACKGROUND: Data on the implementation of prehospital large vessel occlusion (LVO) scales to identify and triage patients with acute ischemic stroke (AIS) in the field are limited, with the majority of studies occurring outside the USA. OBJECTIVE: To report our long-term experience of a US countywide emergency medical services (EMS) acute stroke triage protocol using the Rapid Arterial oCclusion Evaluation (RACE) score. METHODS: Our prospective database was used to identify all consecutive patients triaged within Lucas County, Ohio by the EMS with (1) a RACE score ≥5, taken directly to an endovascular capable center (ECC) as RACE-alerts (RA) and (2) a RACE score <5, taken to the nearest hospital as stroke-alerts (SA). Baseline demographics, RACE score, time metrics, final diagnosis, treatments, and clinical and angiographic outcomes were captured. The sensitivity and specificity for patients with a RACE score ≥5 with LVO, eligible for mechanical thrombectomy (MT), were calculated. RESULTS: Between July 2015 and June 2018, 492 RA and 1147 SA were triaged within our five-hospital network. Of the RA, 37% had AIS secondary to LVOs. Of the 492 RA and 1147 SA, 125 (25.4%) and 38 (3.3%), respectively, underwent MT (OR=9.9; 95% CI 6.8 to 14.6; p<0.0001). Median times from onset-to-ECC arrival (74 vs 167 min, p=0.03) and dispatch-to-ECC arrival (31 vs 46 min, p=0.0002) were shorter in the RA-MT than in the SA-MT cohort. A RACE cut-off point ≥5 showed a sensitivity and specificity of 0.77 and 0.75 for detection of patients with LVO eligible for MT, respectively. CONCLUSIONS: We have demonstrated the long-term feasibility of a countywide EMS-based prehospital triage protocol using the RACE Scale within our hospital network.

Stroke care: initial data from a county-based bypass protocol for patients with acute stroke.

BACKGROUND: Early identification and transfer of patients with acute stroke to a primary or comprehensive stroke center results in favorable outcomes. OBJECTIVE: To describe implementation and results of an emergency medical service (EMS)-driven stroke protocol in Lucas County, Ohio. METHOD: All county EMS personnel (N=464) underwent training in the Rapid Arterial oCclusion Evaluation (RACE) score. The RACE Alert (RA) protocol, whereby patients with stroke and a RACE score ≥5 were taken to a facility that offered advanced therapy, was implemented in July 2015. During the 6-month study period, 109 RAs were activated. Time efficiencies, diagnostic accuracy, and mechanical thrombectomy (MT) outcomes were compared with standard 'stroke-alert' (N=142) patients from the preceding 6 months. RESULTS: An increased treatment rate (25.6% vs 12.6%, p<0.05) and improved time efficiency (median door-to-CT 10 vs 28 min, p<0.05; door-to-needle 46 vs 75 min, p<0.05) of IV tissue plasminogen activator within the RA cohort was achieved. The rate of MT (20.1% vs 7.7%, p=0.06) increased and treatment times improved, including median arrival-to-puncture (68 vs 128 min, p=0.04) and arrival-to-recanalization times (101 vs 205 min, p=0.001) in favor of the RA cohort. A non-significant trend towards improved outcome (50% vs 36.4%, p=0.3) in the RA cohort was noted. The RA protocol also showed improved diagnostic specificity for ischemic stroke (52.3% vs 30.1%, p<0.05). CONCLUSIONS: Our results indicate that EMS adaptation of the RA protocol within Lucas County is feasible and effective for early triage and treatment of patients with stroke. Using this protocol, we can significantly improve treatment times for both systemic thrombolysis and MT.

Use of intrathoracic pressure regulation therapy in breathing patients for the treatment of hypotension secondary to trauma.

BACKGROUND: Intrathoracic pressure regulation (IPR) therapy has been shown to increase blood pressure in hypotensive patients. The potential value of this therapy in patients with hypotension secondary to trauma with bleeding is not well understood. We hypothesized that IPR would non-invasively and safely enhance blood pressure in spontaneously breathing patients with trauma-induced hypotension. METHODS: This prospective observational cohort study assessed vital signs from hypotensive patients with a systolic blood pressure (SBP) ≤90 mmHg secondary to trauma treated with IPR (ResQGARD™, ZOLL Medical) by pre-hospital emergency medical personnel in three large US metropolitan areas. Upon determination of hypotension, facemask-based IPR was initiated as long as bleeding was controlled. Vital signs were recorded before, during, and after IPR. An increased SBP with IPR use was the primary study endpoint. Device tolerance and ease of use were also reported. RESULTS: A total of 54 patients with hypotension secondary to trauma were treated from 2009 to 2016. The mean ± SD SBP increased from 80.9 ± 12.2 mmHg to 106.6 ± 19.2 mmHg with IPR (p < 0.001) and mean arterial pressures (MAP) increased from 62.2 ± 10.5 mmHg to 81.9 ± 16.6 mmHg (p < 0.001). There were no significant changes in mean heart rate or oxygen saturation. Approximately 75% of patients reported moderate to easy tolerance of the device. There were no safety concerns or reported adverse events. CONCLUSIONS: These findings support the use of IPR to treat trauma-induced hypotension as long as bleeding has been controlled.

Intrathoracic pressure regulation during cardiopulmonary resuscitation: a feasibility case-series.

AIM OF THE STUDY: Intrathoracic pressure regulation (IPR) is a novel, noninvasive therapy intended to increase cardiac output and blood pressure in hypotensive states by generating a negative end expiratory pressure of -12 cm H2O between positive pressure ventilations. In this first feasibility case-series, we tested the hypothesis that IPR improves End tidal (ET) CO2 during cardiopulmonary resuscitation (CPR). ETCO2 was used as a surrogate measure for circulation. METHODS: All patients were treated initially with manual CPR and an impedance threshold device (ITD). When IPR-trained medics arrived on scene the ITD was removed and an IPR device (CirQLATOR™) was attached to the patient's advanced airway (intervention group). The IPR device lowered airway pressures to -9 mmHg after each positive pressure ventilation for the duration of the expiratory phase. ETCO2, was measured using a capnometer incorporated into the defibrillator system (LifePak™). Values are expressed as mean ± SEM. Results were compared using paired and unpaired Student's t test. p values of <0.05 were considered statistically significant. RESULTS: ETCO2 values in 11 patients in the case series were compared pre and during IPR therapy and also compared to 74 patients in the control group not treated with the new IPR device. ETCO2 values increased from an average of 21 ± 1 mmHg immediately before IPR application to an average value of 32 ± 5 mmHg and to a maximum value of 45 ± 5mmHg during IPR treatment (p<0.001). In the control group ETCO2 values did not change significantly. Return of spontaneous circulation (ROSC) rates were 46% (34/74) with standard CPR and ITD versus 73% (8/11) with standard CPR and the IPR device (p<0.001). CONCLUSIONS: ETCO2 levels and ROSC rates were significantly higher in the study intervention group. These findings demonstrate that during CPR circulation may be significantly augmented by generation of a negative end expiratory pressure between each breath.

Use of respiratory impedance in prehospital care of hypotensive patients associated with hemorrhage and trauma: a case series.

BACKGROUND: The respiratory pump can be optimized to enhance circulation in patients with hypotension by having patients spontaneously breathe through a low level of inspiratory resistance. This can be achieved with an impedance threshold device (ITD) designed to provide 7 cm H2O resistance during spontaneous inspiration with minimal resistance during expiration. Little is known about the effects of harnessing this physiological concept to increase blood pressure (BP) in the prehospital setting of care for patients with hypotension caused by blood loss or trauma. In this case series, we report on the feasibility, effectiveness, and safety of rapidly deploying the ITD by first responders to treat hypotension secondary to blood loss and trauma in the urban setting by emergency medical services personnel. METHODS: Hemodynamic data from hypotensive patients (pretreatment systolic BP [SBP] <100 mm Hg) from 3 U.S. cities where the ITD is deployed were evaluated. The primary end point was maximum change in SBP and diastolic BP (DBP) from before to during ITD use in patients with hypotension secondary to documented blood loss or trauma. Secondary end points were device tolerance, whether the patient felt "better," change in heart rate, O2 saturation, and adverse events. RESULTS: Of the 255 hypotensive patients treated, there were 26 categorized with blood loss and 13 with trauma. In this 39-patient subgroup, the SBP and DBP (mean ± SD) increased from 79 ± 14 mm Hg and 48 ± 12 mm Hg before ITD placement to 110 ± 17 mm Hg and 66 ± 14 mm Hg after ITD placement (p < 0.001). Breathing through the ITD resulted in no reported adverse events, was well tolerated, and resulted in feeling "better" in more than 85% of the patients. CONCLUSION: Use of an ITD by emergency medical services personnel on hypotensive spontaneously breathing patients secondary to blood loss and trauma increased SBP and DBP and was feasible, well tolerated, and not associated with adverse effects (e.g., increased bleeding).

The impedance threshold device (ITD-7)--a new device for combat casualty care to augment circulation and blood pressure in hypotensive spontaneously breathing warfighters.

Inspiration through -7cm H2O resistance results in an increase in venous blood flow back to the heart and a subsequent increase in cardiac output and blood pressure in hypotensive animals and patients. Breathing through the impedance threshold device with 7cm H2O resistance (ITD-7) also reduces intracranial pressure with each inspiration, thereby providing greater blood flow to the brain. A new device called an ITD-7 was developed to exploit these physiological mechanisms to buy time in hypotensive War Fighters when other therapies are not readily available. Animal and clinical data with the ITD-7 demonstrate the potential value and limitations of this new non-invasive approach to enhancing circulation.