Acute Respiratory Distress Syndrome, Diaphragm Injury, Neuromuscular Blockade
Conditions
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study feasibility - number of participating centers | Through study completion, an average of 18 months | The number of centers that participate in the study |
| Study feasibility - number of trained sonographers in study | Through study completion, an average of 18 months | The number of trained sonographers who collect measurements with ultrasound in the study |
| Study feasibility - enrolment rate | Through study completion, an average of 18 months | Percentage of potentially eligible patients in ROSE trial who are enrolled in ROSETTA |
| Study feasibility - measurement acquisition rate | Through study completion, an average of 18 months | Percentage of scheduled study measurements that are actually collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm function | Study day 7 | Maximal diaphragm thickening fraction |
| Changes in diaphragm thickness over time with or without neuromuscular blockade | First week of study | — |
Countries
United States
Outcome results
None listed