Randomized, Placebo-controlled Trial of Inhaled Treprostinil for Patients at Risk for Acute Respiratory Distress Syndrome.

Rationale: Inhaled treprostinil may improve oxygenation and have additional antiinflammatory effects in early acute hypoxemic respiratory failure, potentially preventing or reducing the severity of acute respiratory distress syndrome (ARDS).Objectives: To determine whether administration of inhaled treprostinil to patients at risk for ARDS is feasible, safe, and efficacious.Methods: We performed a double-blind, placebo-controlled, single-center randomized pilot trial at a quaternary care academic medical center. Patients with acute hypoxemia due to pneumonia or signs of low-pressure pulmonary edema with a unilateral or bilateral infiltrate on chest imaging and a 4 L/min supplemental oxygen requirement not requiring positive pressure ventilation were evaluated. Randomized patients received study drug or placebo (2:1 ratio). Treatment was initiated at 6 breaths every 4 hours and titrated up to 12 breaths. Subjects were maintained on treatment for 7 days and then tapered off over a period of 4 days. Study drug was stopped if positive pressure ventilation was required (invasive or noninvasive).Results: Fourteen patients were enrolled over a period of 31 months. Baseline characteristics were not significantly different between treatment groups with respect to age, sex, race, Acute Physiologic Assessment and Chronic Health Evaluation score, lung injury prediction score, or baseline mean oxygen saturation as measured by pulse oximetry (SpO2):fraction of inspired oxygen (FiO2) ratio. Trends in daily baseline and 30-minute postdose SpO2:FiO2 ratio for all treatment points were not significantly different between placebo and treprostinil. Four patients required positive pressure ventilation in the treprostinil group versus one in the placebo group.Conclusions: Inhaled treprostinil administration is feasible in patients at risk for ARDS but was not associated with improvement in the SpO2:FiO2 ratio relative to placebo. Drug-associated adverse events were not severe nor unexpected based on the known adverse effect profile of inhaled treprostinil. The clinical benefit of this intervention is unclear at this time in the absence of larger studies.Clinical trial registered with Clinicaltrials.gov (NCT02370095).

The impact of family visitor restrictions on healthcare workers in the ICU during the COVID-19 pandemic.

PURPOSE: To obtain information on how family visitor restriction during the COVID-19 pandemic has impacted the workplace experience of physicians and nurses in the medical intensive care unit, and to assess differences by profession. MATERIALS AND METHODS: We developed a survey containing closed- and open-ended questions, applying both quantitative and qualitative analyses to our results. RESULTS: Of the 74 respondents, 29 (38%) were nurses and 45 (62%) were physicians. Nurses reported positive changes to daily workflow and the ability to provide medical care, while physicians reported negative changes in these areas. Both groups reported decreased comprehension and increased distress among families, and decreased ability to provide end-of-life care. For the qualitative analysis, eight themes were identified: the patient's room as space, creation of a new space through virtual communication, time, increased complexity of care, challenges around the use of technology, adjustments to team roles and responsibilities, desire for families to return, and internal tension. CONCLUSION: Intensive care physicians and nurses reported both positive and negative effects of family visitor restriction during the COVID-19 pandemic, with significant differences based on profession. Both groups expressed concern for an overall negative impact of visitor restriction on healthcare workers, patients, and their families.