Reevaluation Of Systemic Early Neuromuscular Blockade
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 Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury
You can join if…
Open to people ages 18 years and up
- Age > 18 years
- Presence of all of the following conditions for < 48 hours:
- 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.
You CAN'T join if...
- 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 (Appendix A2)
- . 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)
- UCSF Fresno accepting new patients
Fresno, California, 93701, United States
- UCSF Medical Center accepting new patients
San Francisco, California, 94143, United States
- Stanford University Hospital accepting new patients
Stanford, California, 94305, United States
- UC Davis Medical Center accepting new patients
Sacramento, California, 95817, United States
- Ronald Reagan UCLA Medical Center accepting new patients
Los Angeles, California, 90095, United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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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.