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One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation

Patel, Bhakti K., MD1; Wolfe, Krysta S., MD1; MacKenzie, Erica L., MD2; Salem, Dhafer, MD3; Esbrook, Cheryl L., OTR/L4; Pawlik, Amy J., PT4; Stulberg, Megan, PT4; Kemple, Crystal, OTR/L4; Teele, Megan, PT4; Zeleny, Erin, OTR/L4; Macleod, Julia, PT4; Pohlman, Anne S., MSN1; Hall, Jesse B., MD1; Kress, John P., MD1

doi: 10.1097/CCM.0000000000003124
Clinical Investigations

Objectives: Many survivors of acute respiratory distress syndrome have poor long-term outcomes possibly due to supportive care practices during “invasive” mechanical ventilation. Helmet noninvasive ventilation in acute respiratory distress syndrome may reduce intubation rates; however, it is unknown if avoiding intubation with helmet noninvasive ventilation alters the consequences of surviving acute respiratory distress syndrome.

Design: Long-term follow-up data from a previously published randomized controlled trial.

Patients: Adults patients with acute respiratory distress syndrome enrolled in a previously published clinical trial.

Setting: Adult ICU.

Intervention: None.

Measurements and Main Results: The primary outcome was functional independence at 1 year after hospital discharge defined as independence in activities of daily living and ambulation. At 1 year, patients were surveyed to assess for functional independence, survival, and number of institution-free days, defined as days alive spent living at home. The presence of ICU-acquired weakness and functional independence was also assessed by a blinded therapist on hospital discharge. On hospital discharge, there was a greater prevalence of ICU-acquired weakness (79.5% vs 38.6%; p = 0.0002) and less functional independence (15.4% vs 50%; p = 0.001) in the facemask group. One-year follow-up data were collected for 81 of 83 patients (97.6%). One-year mortality was higher in the facemask group (69.2% vs 43.2%; p = 0.017). At 1 year, patients in the helmet group were more likely to be functionally independent (40.9% vs 15.4%; p = 0.015) and had more institution-free days (median, 268.5 [0–354] vs 0 [0–323]; p = 0.017).

Conclusions: Poor functional recovery after invasive mechanical ventilation for acute respiratory distress syndrome is common. Helmet noninvasive ventilation may be the first intervention that mitigates the long-term complications that plague survivors of acute respiratory distress syndrome managed with noninvasive ventilation.

1Department of Medicine, Section of Pulmonary/Critical Care, University of Chicago, Chicago, IL.

2Department of Medicine, Internal Medicine Residency Program, University of Chicago, Chicago, IL.

3Department of Medicine, Internal Medicine Residency, Mercy Hospital, Chicago, IL.

4Department of Therapy Services, University of Chicago, Chicago IL.

Clinical Trial Registration: Identifier: NCT01680783.

Drs. Patel, Pohlman, Hall, and Kress participated in the conception of the trial. Drs. Patel, Esbrook, Pawlik, Hall, and Kress participated in study design. Drs. Patel, Pohlman, and Kress recruited patients and collected data. Drs. Wolfe, MacKenzie, Salem, Esbrook, Pawlik, Stulberg, Kemple, Teele, Zeleny, and Macleod collected data alone. Drs. Patel, Wolfe, MacKenzie, Pawlik, Hall, and Kress analyzed the data. All authors participated in the interpretation of the results. Dr. Patel drafted the article. All authors have seen and approved the final version of the article.

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Supported, in part, by the Daniel J. Edelman grant, a gift of the Edelman family; NIH/National Heart, Lung and Blood Institute T32 HL007605 Research training in Respiratory Biology; Parker B. Francis Foundation.

Drs. Patel’s, Stulberg’s, and Kemple’s institutions received funding from a Daniel Edelman grant. Dr. Patel’s institution received funding from a Parker B. Francis Foundation Career Development Award (salary support). Drs. Patel’s and Wolfe’s institutions received funding from the National Institutes of Health (NIH) T32 salary support, and they received support for article research from the NIH. Dr. Pohlman received funding from B. Braun (consultant). The remaining authors have disclosed that they do not have any potential conflicts of interest.

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