Screening of ARDS patients using standardized ventilator settings: influence on enrollment in a clinical trial
The American–European consensus conference (AECC) definition for acute respiratory distress syndrome (ARDS) requires a PaO2/FIO2≤200 mmHg, regardless of ventilator settings. We report the results of using standardized ventilator settings to screen and enroll ARDS patients in a clinical trial of high-frequency oscillatory ventilation (HFOV), including the impact on study enrollment, and potential effects on study outcome.
Prospective cohort study.
Intensive care units in two teaching hospitals.
A consecutive sample of 41 patients with early ARDS by AECC criteria (baseline PaO2/FIO2≤200) who met all other inclusion/exclusion criteria for the HFOV trial.
Patients were placed on standardized ventilator settings (tidal volume 7–8 ml/kg, PEEP 10 cmH2O, FIO2 1.0), and the PaO2/FIO2 was reassessed after 30 min.
Seventeen patients (41.5%) had PaO2/FIO2 ratios that remained ≤200 mmHg [Persistent ARDS; PaO2/FIO2=94±36 (mean±SD)] and went on to inclusion in the HFOV study; however, in 24 patients (58.5%) the PaO2/FIO2 was >200 mmHg [Transient ARDS; PaO2/FIO2=310±74] and these patients were ineligible for the HFOV study. The ICU mortality was significantly greater (52.9 vs 12.5%; p=0.01) in the Persistent ARDS patients.
The use of these standardized ventilatory significantly impacted the PaO2/FIO2 ratio and therefore the ARDS prevalence and trial enrollment. These results have effects on the evaluation of the current ARDS literature and conduct of clinical trials in ARDS and hence consideration should be given to the use of standardized ventilatory settings in future ARDS trials.
KeywordsAdult respiratory distress syndrome Artificial respiration Mechanical ventilation Anoxemia Diagnosis
We thank the following individuals who participated in preliminary discussions regarding the design of the multi-center HFOV study: M.B.P. Amato, J.T. Granton, S. Grasso, N.R. MacIntyre, V.M. Ranieri, and A.S. Slutsky. Thanks also to R. MacDonald for his assistance with patient screening and data collection. The Ontario Thoracic Society and Physicians’ Services Incorporated supported this work. N. Ferguson was supported by a Canadian Institutes of Health Research / Canadian Lung Association Post-Doctoral Fellowship.
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