SHS_300302 OMAS FUWA 13119

Reevaluation Of Systemic Early Neuromuscular Blockade

This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged. PRIMARY OBJECTIVE: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 (NMB). Early neuromuscular blockade will improve mortality prior to discharge home before day 90, in patients with moderate-severe ARDS. By preventing active expiration, and/or patient ventilator dyssynchrony, neuromuscular blockade may create a more homogenous distribution of airway pressures and tidal volumes, preventing barotrauma/volutrauma and atelectrauma resulting in less ventilator-induced lung injury.

Inclusion Criteria

•Age > 18 years
•Presence of all of the following conditions for < 48 hours: i. PaO2/FiO2 < 150 with PEEP >/= 8 cm H2O OR, if ABG not available, SaO2/FiO2 ratio that is equivalent to a PaO2/FiO2 < 150 with PEEP >/= 8 cm H2O , and a confirmatory SaO2/FiO2 ratio that is again equivalent 1-6 hours later. 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.
•Patients must be enrolled within 48 hours of meeting inclusion criteria.

Exclusion Criteria:

•Lack of informed consent
•Continuous neuromuscular blockade at enrollment
•Known pregnancy
•Currently receiving ECMO therapy
•Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting
•Home mechanical ventilation (non-invasive ventilation or via tracheotomy) 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 (Appendix A2)
•Bone marrow transplantation within the last 1 year
•Expected duration of mechanical ventilation of < 48 hours
•Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs
•Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status greater than 6 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 may potentiate neuromuscular blockade 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
>120 hours of mechanical ventilation
•P/F < 200 mmHg at the time of randomization (if available)
Phase III
NCT02509078
Heart and Vascular, All Other
Interventional Cardiology
Shane O'Mahony, M.D.
University of Washington
  • Swedish Medical Center