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

Withdrawn

• Conditions: Neuromuscular Blockade; Acute Respiratory Distress Syndrome; Diaphragm Injury

• Registration Number: NCT03132896
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Study Start: 2017-10-12
• Status Verified: 2018-07
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Diaphragm function	Study day 7	Maximal diaphragm thickening fraction
Changes in diaphragm thickness over time with or without neuromuscular blockade	First week of study

Trial Locations

Locations (6)

Baystate Health; 🇺🇸 Springfield, Massachusetts, United States

Brigham and Women's Health; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States