Reevaluation Of Systemic Early neuromuscular blockade (ROSE study).
To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS in comparison to a control group with no routine early neuromuscular blockade.
Key Inclusion Criteria:
1. Age > 18 years
2. Endotracheal ventilation for < 5 days (120 hours)
3. Presence of all of the following conditions for < 48 hours
i. (I) PaO2/FiO2 < 150 with PEEP > 8 cm H2O.a,b,c
OR, IF ABG NOT AVAILABLE
SpO2/FiO2 ratio that is equivalent to a PaO2/FiO2 < 150 with PEEP > 8 cm H2O (Appendix A1), and a confirmatory SpO2/FiO2 ratio between 1-6 hours after the initial Sp02/Fi02 ratio determination. c,d
ii. Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
iii. Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present (Appendix L)
a, If altitude >1000m, then PaO2/FiO2 < 150 x (PB/760).
b These inclusion criteria ensure a non-transient, established hypoxia that persists despite elevated PEEP and time. Initial, post-intubation, PEEP is typically < 8 cm H2O.
c The qualifying PaO2/FiO2 or the SpO2/FiO2 must be from intubated patients receiving at least 8 cm H2O PEEP.
d. When hypoxia is documented using pulse oximetry, a confirmatory SpO2/FiO2 ratio is required to further establish persistent hypoxia. Qualifying SpO2/FiO2 must use SpO2 values less than or equal to 96% Qualifying SpO2 must be measured at least 10 minutes after any change to FiO2.
The 48-hour enrollment time window begins when criteria 1-3 are met. Criteria may be met at either the Network or referring hospital. The first qualifying SpO2/FiO2 (not the confirmatory SpO2/FiO2) is used determine this time window.
See clinicaltrials.gov for full details.
Massachussets General Hospital
- Providence Portland Medical Center