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Reevaluation Of Systemic Early Neuromuscular Blockade — ROSE  

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Reevaluation Of Systemic Early Neuromuscular Blockade

Clinical Trial Summary

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.

Clinical Trial Description

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).

PRIMARY HYPOTHESIS:

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. ;

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
Clinical Trial Details
NCT number NCT02509078
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase Phase 3
Start date January 4, 2016
Completion date April 4, 2019
View Details
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