NCT04832789

Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO

Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO (ULTIMATE) Pilot Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Research Question for the Full ULTIMATE Randomized Clinical Trial (RCT): What is the effect of ultra-protective ventilation facilitated by extracorporeal membrane oxygenation (ECMO) versus best current conventional ventilation (CV) on all-cause hospital mortality among patients with early moderate-severe acute respiratory distress syndrome (ARDS)? Secondary Research Questions: Among patients with early moderate-severe ARDS, what is the effect of ultra-protective ventilation versus CV on: (1) duration of mechanical ventilation; (2) duration of ICU and hospital stay; (3) organ dysfunction; (4) barotrauma; and (5) mortality at other time-points (ICU discharge, 28-day, 60-day)? The ULTIMATE Pilot Study: Before embarking on a definitive multinational trial to address the questions listed above, the ULTIMATE Pilot Study has these 3 specific feasibility objectives: 1. To assess adherence to our explicit mechanical ventilation protocols, with particular focus on delivered tidal volumes in both groups; 2. To estimate the rate of patient recruitment and understand barriers to recruitment; and 3. To measure and understand the reasons for crossovers or rescue by ECMO in the control group. In addition, we will monitor safety issues, recording serious adverse events in both groups.

Conditions

• ARDS

Interventions

Type	Name	Description
DEVICE	Venovenous ECMO	Venovenous ECMO

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2021-04-06
• Last updated: 2021-04-06

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study