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Not Recruiting
Trial ID: NCT02509078
Reevaluation Of Systemic Early Neuromuscular Blockade
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)
Professor of Emergency Medicine
Inclusion Criteria
1. Age > 18 years
2. 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:
1. Lack of informed consent
2. Continuous neuromuscular blockade at enrollment
3. Known pregnancy
4. Currently receiving ECMO therapy
5. Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting
6. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for
CPAP/BIPAP used solely for sleep-disordered breathing
7. Actual body weight exceeding 1 kg per centimeter of height
8. Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2)
9. Bone marrow transplantation within the last 1 year
10. Expected duration of mechanical ventilation of < 48 hours
11. Decision to withhold life-sustaining treatment; except in those patients committed to
full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs
12. Moribund patient not expected to survive 24 hours; if CPR provided, assess for
moribund status greater than 6 from CPR conclusion
13. Diffuse alveolar hemorrhage from vasculitis
14. Burns > 70% total body surface
15. Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol
16. Previous hypersensitivity or anaphylactic reaction to cisatracurium
17. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair
spontaneous ventilation (Appendix A2)
18. Neurologic conditions undergoing treatment for intracranial hypertension
19. Enrollment in an interventional ARDS trial with direct impact on neuromuscular
blockade and PEEP
20. >120 hours of mechanical ventilation
21. P/F < 200 mmHg at the time of randomization (if available)
drug: Cisatracurium Besylate
Not Recruiting
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