Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm

Withdrawn before enrolling

Conditions studied: Acute Respiratory Distress Syndrome, Diaphragm Injury, Neuromuscular Blockade

In brief

ROSETTA is a multi-centre study evaluating the time course of diaphragm thickness and function following exposure to neuromuscular blockade or control in patients with acute respiratory distress. ROSETTA is an ancillary study to the Re-evaluation of Systemic Early Neuromuscular Blockade (ROSE) trial (NCT02509078). It is designed to (1) test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation and (2) determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome (ARDS).

Key facts

Study ID

NCT03132896

Run by

University Health Network, Toronto

People needed

0

Starts

2017-10-12

Expected to finish

2018-12-01

Last updated by the study team

2019-10-14

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients enrolled in the ROSE PETAL trial (adult patients with moderate-severe acute respiratory distress syndrome who have received invasive mechanical ventilation for less than 5 days)

You may not qualify if…

• Patients expected to be extubated within 24 hours of screening for eligibility
• Patients with a contraindication to chest ultrasonography (chest tubes inserted over right lower chest wall; chest wall trauma)

Where it is running

• Brigham and Women's Health — Boston, Massachusetts, United States
• Baystate Health — Springfield, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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