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Randomized Feasibility Trial of a Low Tidal Volume-Airway Pressure Release Ventilation Protocol Compared With Traditional Airway Pressure Release Ventilation and Volume Control Ventilation Protocols.

ABSTRACT: OBJECTIVES:Low tidal volume (= tidal volume ? 6?mL/kg, predicted body weight) ventilation using volume control benefits patients with acute respiratory distress syndrome. Airway pressure release ventilation is an alternative to low tidal volume-volume control ventilation, but the release breaths generated are variable and can exceed tidal volume breaths of low tidal volume-volume control. We evaluate the application of a low tidal volume-compatible airway pressure release ventilation protocol that manages release volumes on both clinical and feasibility endpoints. DESIGN:We designed a prospective randomized trial in patients with acute hypoxemic respiratory failure. We randomized patients to low tidal volume-volume control, low tidal volume-airway pressure release ventilation, and traditional airway pressure release ventilation with a planned enrollment of 246 patients. The study was stopped early because of low enrollment and inability to consistently achieve tidal volumes less than 6.5?mL/kg in the low tidal volume-airway pressure release ventilation arm. Although the primary clinical study endpoint was PaO2/FIO2 on study day 3, we highlight the feasibility outcomes related to tidal volumes in both arms. SETTING:Four Intermountain Healthcare tertiary ICUs. PATIENTS:Adult ICU patients with hypoxemic respiratory failure anticipated to require prolonged mechanical ventilation. INTERVENTIONS:Low tidal volume-volume control, airway pressure release ventilation, and low tidal volume-airway pressure release ventilation. MEASUREMENTS AND MAIN RESULTS:We observed wide variability and higher tidal (release for airway pressure release ventilation) volumes in both airway pressure release ventilation (8.6?mL/kg; 95% CI, 7.8-9.6) and low tidal volume-airway pressure release ventilation (8.0; 95% CI, 7.3-8.9) than volume control (6.8; 95% CI, 6.2-7.5; p = 0.005) with no difference between airway pressure release ventilation and low tidal volume-airway pressure release ventilation (p = 0.58). Recognizing the limitations of small sample size, we observed no difference in 52 patients in day 3 PaO2/ FIO2 (p = 0.92). We also observed no significant difference between arms in sedation, vasoactive medications, or occurrence of pneumothorax. CONCLUSIONS:Airway pressure release ventilation resulted in release volumes often exceeding 12?mL/kg despite a protocol designed to target low tidal volume ventilation. Current airway pressure release ventilation protocols are unable to achieve consistent and reproducible delivery of low tidal volume ventilation goals. A large-scale efficacy trial of low tidal volume-airway pressure release ventilation is not feasible at this time in the absence of an explicit, generalizable, and reproducible low tidal volume-airway pressure release ventilation protocol.

SUBMITTER: Hirshberg EL

PROVIDER: S-EPMC6250244 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:We observed that increasing fresh gas flow (FGF) decreased exhaled tidal volume (VT) during pressure control ventilation (PCV). A literature search produced no such description whereby unintended VT changes occur with FGF changes during PCV. METHODS:To model an infant's lungs, 1 lung of a mechanical lung model (Dual Adult TTL 1600; Michigan Instruments, Inc, Grand Rapids, MI) was set at a compliance of 0.0068 L/cm H2O. An Rp50 resistor (27.2 cm H2O/L/s at 15 L/min) simulated normal bronchial resistance. The simulated lung was connected to a pediatric breathing circuit via a 3.5-mm cuffed endotracheal tube. A ventilator with PCV capability (Model 7900; Aestiva, GE Healthcare, Madison, WI) measured exhaled VT, and a flow monitor (NICO; Respironics, Murraysville, PA) measured peak inspiratory flow, positive end-expiratory pressure (PEEP), and peak inspiratory pressure. In PCV mode, exhaled VT displayed by the ventilator at FGF rates of 1, 6, 10, and 15 L/min was manually recorded across multiple ventilator settings. This protocol was repeated for the Avance CS2 anesthesia machine (GE Healthcare). RESULTS:For the Aestiva, higher FGF rates in PCV mode decreased exhaled VT. Exhaled VT for FGFs of 1, 6, 10, and 15 L/min were on average 48, 34.9, 16.5, and 10 mL, respectively, at ventilator settings of inspiratory pressure of 10 cm H2O, PEEP of 0 cm H2O, and respiratory rate of 20 breaths/min. This is a decrease by up to 27%, 65.6%, and 79.2% when FGFs of 6, 10, and 15 L/min are compared with a FGF of 1 L/min, respectively. In the GE Avance CS2 at the same ventilator settings, VT for FGF rates of 1, 6, 10, and 15 L/min were on average 46, 43, 40.4, and 39.7 mL, respectively. The FGF effect on VT was not as pronounced with the GE Avance CS2 as with the GE Aestiva. CONCLUSIONS:FGF has a significant effect on VT during PCV in the Aestiva bellows ventilator, suggesting caution when changing FGF during PCV in infants. Our hypothesis is that at higher FGF rates, an inadvertent PEEP is developed by the flow resistance of the ventilator relief valve that is not recognized by the ventilator. In turn, less change in pressure is needed to reach the set inspiratory pressure, resulting in lower VT delivery at higher FGF rates. This underappreciated FGF-VT interaction during PCV with a bellows ventilator may be clinically significant in pediatric patients; prospective data collection in patients is needed for further evaluation.

Project description:OBJECTIVE:Critical organ shortages have resulted in ex vivo lung perfusion gaining clinical acceptance for lung evaluation and rehabilitation to expand the use of donation after circulatory death organs for lung transplantation. We hypothesized that an innovative use of airway pressure release ventilation during ex vivo lung perfusion improves lung function after transplantation. METHODS:Two groups (n = 4 animals/group) of porcine donation after circulatory death donor lungs were procured after hypoxic cardiac arrest and a 2-hour period of warm ischemia, followed by a 4-hour period of ex vivo lung perfusion rehabilitation with standard conventional volume-based ventilation or pressure-based airway pressure release ventilation. Left lungs were subsequently transplanted into recipient animals and reperfused for 4 hours. Blood gases for partial pressure of oxygen/inspired oxygen fraction ratios, airway pressures for calculation of compliance, and percent wet weight gain during ex vivo lung perfusion and reperfusion were measured. RESULTS:Airway pressure release ventilation during ex vivo lung perfusion significantly improved left lung oxygenation at 2 hours (561.5 ± 83.9 mm Hg vs 341.1 ± 136.1 mm Hg) and 4 hours (569.1 ± 18.3 mm Hg vs 463.5 ± 78.4 mm Hg). Likewise, compliance was significantly higher at 2 hours (26.0 ± 5.2 mL/cm H2O vs 15.0 ± 4.6 mL/cm H2O) and 4 hours (30.6 ± 1.3 mL/cm H2O vs 17.7 ± 5.9 mL/cm H2O) after transplantation. Finally, airway pressure release ventilation significantly reduced lung edema development on ex vivo lung perfusion on the basis of percentage of weight gain (36.9% ± 14.6% vs 73.9% ± 4.9%). There was no difference in additional edema accumulation 4 hours after reperfusion. CONCLUSIONS:Pressure-directed airway pressure release ventilation strategy during ex vivo lung perfusion improves the rehabilitation of severely injured donation after circulatory death lungs. After transplant, these lungs demonstrate superior lung-specific oxygenation and dynamic compliance compared with lungs ventilated with standard conventional ventilation. This strategy, if implemented into clinical ex vivo lung perfusion protocols, could advance the field of donation after circulatory death lung rehabilitation to expand the lung donor pool.

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Randomized Feasibility Trial of a Low Tidal Volume-Airway Pressure Release Ventilation Protocol Compared With Traditional Airway Pressure Release Ventilation and Volume Control Ventilation Protocols.

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