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



Status:Recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:19 - Any
Updated:7/8/2018
Start Date:October 12, 2017
End Date:December 2019
Contact:Jenna Wong, MSc
Email:jenna.wong@uhn.ca
Phone:416-340-3096

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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).

A growing body of evidence strongly suggests that mechanical ventilation injures the
respiratory muscles, particularly the diaphragm. Due to the deleterious effects of diaphragm
inactivity on diaphragm function, there are important concerns about the risk of diaphragm
weakness and difficult liberation from mechanical ventilation following neuromuscular
blockade. Sonographic measurements of diaphragm thickness provide a potentially useful window
for studying diaphragm injury and function during mechanical ventilation.

Patients enrolled in the ROSE trial (randomizing patients with moderate-severe acute
respiratory distress syndrome to receive neuromuscular blockade or control for 2 days) will
be eligible for participation in this study. Study patients will undergo regular diaphragm
ultrasound to assess diaphragm thickness and activity during the first week of the study.
Diaphragm function will be assessed by ultrasound on study days 7, 14, 21, and 28.

ROSETTA is designed to:

1. Test the feasibility of a multi-center evaluation of the diaphragm structure and
function by ultrasound during mechanical ventilation;

2. Determine whether neuromuscular blockade accelerates atrophy and dysfunction of the
diaphragm in patients with acute respiratory distress syndrome; and

3. Evaluate whether patients with greater diaphragm dysfunction exhibit worse functional
outcomes compared to patients without diaphragm dysfunction.

Inclusion Criteria:

1. 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)

Exclusion Criteria:

1. Patients expected to be extubated within 24 hours of screening for eligibility

2. Patients with a contraindication to chest ultrasonography (chest tubes inserted over
right lower chest wall; chest wall trauma)
We found this trial at
6
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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45 Francis Street
Boston, Massachusetts 02115
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Boston, MA
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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Springfield, Massachusetts 01199
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Springfield, MA
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