a study on Respiratory Distress Syndrome
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 .
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.
The trial will accrue a maximum of 1408 patients. Patients will be recruited from the emergency departments, intensive care units and other acute care areas of the PETAL Network Clinical Centers and randomized to the active (NMB) or control. The overall strategy is to screen, consent, and enroll early, every newly intubated, acutely ill or post-operative, eligible patient at each site, using clinically obtained pulse oximetry and blood gases.
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.
Acute Respiratory Distress Syndrome ARDS neuromuscular blocker cisatracurium
Open to people ages 18 years and up
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.
120 hours of mechanical ventilation
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02509078.
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