ROSE study inclusion and exclusion criteria

(Originally posted on: June 8, 2016

INCLUSION
1. Age > 18 years
2. Presence of all of the following conditions for < 48 hours a. (I) PaO2/FiO2 < 150 with PEEP > 8 cm H2O. 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.
b. Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
c. 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)

EXCLUSION

Continuous neuromuscular blockade at enrollment

More than 48 hours since meeting inclusion criteria
Endotracheal ventilation for >120 hours
Known pregnancy
Currently receiving ECMO therapy
Chronic respiratory failure defined as PaCO2 > 60 in the outpatient setting
Home mechanical ventilation except for CPAP/BIPAP used solely for sleep-disordered breathing
Actual body weight exceeding 1 kg per centimeter of height
Severe chronic liver disease defined as a Child-Pugh score of 12-15*
Bone marrow transplantation within the last 1 year
Expected duration of mechanical ventilation of < 48 hours Plan to withhold life-sustaining treatment; except no CPR order if an actual cardiac arrest occurs Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status ≥ 6h from CPR conclusion Diffuse alveolar hemorrhage from vasculitis Burns > 70% total body surface
Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol
Previous hypersensitivity or anaphylactic reaction to cisatracurium
Neuromuscular conditions that potentiate NMB and/or impair spontaneous ventilation
Neurologic conditions undergoing treatment for intracranial hypertension
Enrollment in an interventional ARDS trial with direct impact on neuromuscular blockade and PEEP
PaO2/FiO2 (if available) >200 after meeting inclusion criteria and before randomization
MD refusal or Lack of informed consent :

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