Early Use of Aprv in Critically Ill Adults with Moderate-to-Severe Ards: A Pilot Feasibility Trial

ABSTRACT

INTRODUCTION: Airway pressure release ventilation (APRV) may be an alternative to low tidal volume ventilation for patients with acute respiratory distress syndrome (ARDS). We conducted an investigator-initiated, pilot feasibility randomized controlled study (RCT) comparing APRV to low tidal volume ventilation in critically ill adults with ARDS (ClinicalTrials.gov identifier NCT 04156438). METHOD(S) Participants with moderate-to-severe ARDS admitted to an intensive care unit (ICU) in Regina, Saskatchewan, were randomized on an open-label basis to APRV or low tidal volume ventilation, over a one-year period. The primary feasibility outcomes were the informed consent rate, recruitment rate, and protocol adherence rate. A successful informed consent rate was defined as at least 70% of eligible patients approached for study participation consenting to participation. Enrollment of at least 15 participants during the one-year recruitment period was considered a successful recruitment rate. Protocol adherence was defined as the number of patient-days of complete adherence to the study protocol, with a rate of at least 80% considered successful. The secondary efficacy outcomes were 28-day mortality, in-hospital mortality, ICU length of stay, hospital length of stay, length of mechanical ventilation, and incidence of tracheostomy. RESULT(S) Due to interruptions in study recruitment from the COVID-19 pandemic, this study took place between July 1, 2020 to December 31, 2021 to ensure a one-year recruitment window. Of the 165 ARDS patients admitted to the ICU during this period, 42 (25.5%) were screened for eligibility, with 17/42 patients (40.5%) meeting the eligibility criteria. 13/17 (76.5%) secondary decision makers were approached for informed consent, with only one (7.7%) giving consent for participation. Clinical documentation limited ability to assess protocol adherence. Efficacy outcomes were not analyzed due to low recruitment. No adverse events associated with trial participation were identified. CONCLUSION(S) Our study did not meet the pre-specified feasibility outcomes for recruitment, informed consent, or protocol adherence. Future studies of ventilation strategies for ARDS at our center may need to consider the impacts of COVID-19 pandemic on recruitment strategies, institutional resources and policies.