Background A recent out-of-hospital cardiac arrest (OHCA) clinical trial showed improved survival to hospital discharge (HD) with favorable neurologic function for patients with cardiac arrest of cardiac origin treated with active compression decompression cardiopulmonary resuscitation (CPR) plus an impedance threshold device (ACD+ICD) versus standard (S) CPR. The current analysis examined whether treatment with ACD+ITD is more effective than standard (S-CPR) for all cardiac arrests of non-traumatic origin, regardless of the aetiology. Methods This is a secondary analysis of data from a randomized, prospective, multicenter, intention-to-treat, OHCA clinical trial. Adults with presumed non-traumatic cardiac arrest were enrolled and followed for one year post arrest. The primary endpoint was survival to hospital discharge (HD) with favorable neurologic function (modified Rankin Scale score ≤3). Results Between October 2005 to July 2009, 2738 patients were enrolled (S-CPR = 1335; ACD+ITD =1403). Survival to HD with favorable neurologic function was greater with ACD+ITD compared with S-CPR: 7.9% versus 5.7%, (OR 1.42, 95% CI 1.04, 1.95, p=0.027). One-year survival was also greater: 7.9% versus 5.7%, (OR 1.43, 95% CI 1.04, 1.96, p=0.026). Nearly all survivors in both groups had returned to their baseline neurological function by one year. Major adverse event rates were similar between groups. Conclusions Treatment of out-of-hospital non-traumatic cardiac arrest patients with ACD+ITD resulted in a significant increase in survival to hospital discharge with favorable neurological function when compared with S-CPR. A significant increase survival rates was observed up to one year after arrest in subjects treated with ACD+ITD, regardless of the etiology of the cardiac arrest. Clinical Trial Registration NCT 00189423 (http://www.clinicaltrials.gov)

BackgroundIntrathoracic 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.MethodsThis 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.ResultsA 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.ConclusionsThese findings support the use of IPR to treat trauma-induced hypotension as long as bleeding has been controlled.

Objectives: Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short-and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. Methods:This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial performed under 21 § CFR 50.24. Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest. Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group.Results: Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6%). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96%) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation/ventricular tachycardia (VF/VT) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [OR] = 3.15, 95% confidence interval [CI] = 1.73 to 5.75;

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Objectives: Intrathoracic pressure regulation therapy (IPRT) 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. Hypothesis: We hypothesized that IPRT 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 by pre-hospital emergency medical personnel with IPRT (ResQGARD) in three large US metropolitan areas. Upon determination of hypotension, facemask-based IPRT was initiated as long as bleeding was controlled. Vital signs were recorded before, during, and after IPRT. An increased SBP with IPRT 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 81 ± 12 mmHg to 107 ± 19 with IPRT (p < 0.0001) and mean arterial pressures (MAP) increased from 62 ± 11 mmHg to 82 ± 17 (p < 0.0001). 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. Conclusion: In patients with hypotension secondary to trauma IPRT increased blood pressure to levels known to provide near normal or normal vital organ blood flow in the vast majority of patients. Patients were treated safely and not over resuscitated with this intervention. These findings support the use of IPRT to treat trauma-induced hypotension as long as bleeding has been controlled.