Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Patel BK

PROVIDER: S-EPMC6005726 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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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 BK Wolfe Krysta S KS MacKenzie Erica L EL Salem Dhafer D Esbrook Cheryl L CL Pawlik Amy J AJ Stulberg Megan M Kemple Crystal C Teele Megan M Zeleny Erin E Macleod Julia J Pohlman Anne S AS Hall Jesse B JB Kress John P JP

Critical care medicine 20180701 7

<h4>Objectives</h4>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.<h4>Design</h4>Long-term follow-up data from a previously pu ...[more]

PMID: 29595563

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Project description:ImportanceNoninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). Delivery of NIV with a helmet may be a superior strategy for these patients.ObjectiveTo determine whether NIV delivered by helmet improves intubation rate among patients with ARDS.Design, setting, and participantsSingle-center randomized clinical trial of 83 patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit at the University of Chicago between October 3, 2012, through September 21, 2015.InterventionsPatients were randomly assigned to continue face mask NIV or switch to a helmet for NIV support for a planned enrollment of 206 patients (103 patients per group). The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Early trial termination resulted in 44 patients randomized to the helmet group and 39 to the face mask group.Main outcomes and measuresThe primary outcome was the proportion of patients who required endotracheal intubation. Secondary outcomes included 28-day invasive ventilator-free days (ie, days alive without mechanical ventilation), duration of ICU and hospital length of stay, and hospital and 90-day mortality.ResultsEighty-three patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n = 24) for the face mask group and 18.2% (n = 8) for the helmet group (absolute difference, -43.3%; 95% CI, -62.4% to -24.3%; P < .001). The number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5, P < .001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, -22.3%; 95% CI, -43.3 to -1.4; P = .02). Adverse events included 3 interface-related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers).Conclusions and relevanceAmong patients with ARDS, treatment with helmet NIV resulted in a significant reduction of intubation rates. There was also a statistically significant reduction in 90-day mortality with helmet NIV. Multicenter studies are needed to replicate these findings.Trial registrationclinicaltrials.gov Identifier: NCT01680783.

Project description:RationaleAlthough noninvasive positive pressure ventilation (NIPPV) is increasingly used in acute respiratory distress syndrome (ARDS) to avoid invasive mechanical ventilation (IMV), the data supporting its benefit for this indication are lacking.ObjectivesTo analyze the all-cause in-hospital mortality rate and length of stay (LOS) for ARDS patients who received NIPPV in the United States (US) compared to those who were initially intubated. Our secondary outcome of interest was to determine the predicting factors for NIPPV failure.MethodsWe used the 2016 National Inpatient Sample database to identify 4,277 adult records with ARDS who required positive pressure ventilation. We divided the cohort into initial treatment with IMV or NIPPV. Then, the NIPPV group was further subdivided into NIPPV failure or success. We defined NIPPV failure as same-patient use of NIPPV and IMV either on the same day or using IMV at a later date. We analyzed the in-hospital mortality, LOS, and NIPPV failure rate. Linear regression of log-transformed LOS and logistic regression of binary outcomes were used to test for associations.ResultsThe NIPPV success group had the lowest mortality rate (4.9% [3.8, 6.4]) and the shortest LOS (7 days [6.6, 7.5]). The NIPPV failure rate was 21%. Sepsis, pneumonia, and chronic liver disease were associated with higher odds of NIPPV failure (adjusted OR: 4.47, 2.65, and 2.23, respectively). There was no significant difference between NIPPV failure and IMV groups in-hospital mortality (26.9% [21.8, 32.8] vs. 25.1% [23.5, 26.9], p=0.885) or LOS (16 [14, 18] vs. 15.6 [15, 16.3], p=0.926).ConclusionsNIPPV success in ARDS exhibits significantly lower hospital mortality rates and shorter LOS compared with IMV, and NIPPV failure exhibits no significant difference in hospital mortality or LOS compared with patients who were initially intubated. Therefore, an initial trial of NIPPV may be considered in ARDS. Sepsis, pneumonia, and chronic liver disease were associated with higher odds of NIPPV failure; these factors should be used to stratify patients to the most suitable ventilation modality.

Dataset Information

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

Publications

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

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