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

Acute Respiratory Distress Syndrome Clinical Trial

— ROSETTA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03132896
• Other study ID #: 16-6360
• Status: Withdrawn
• Start date: October 12, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: July 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Diaphragm Injury
• Neuromuscular Blockade
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study feasibility - number of participating centers	The number of centers that participate in the study	Through study completion, an average of 18 months
Primary	Study feasibility - number of trained sonographers in study	The number of trained sonographers who collect measurements with ultrasound in the study	Through study completion, an average of 18 months
Primary	Study feasibility - enrolment rate	Percentage of potentially eligible patients in ROSE trial who are enrolled in ROSETTA	Through study completion, an average of 18 months
Primary	Study feasibility - measurement acquisition rate	Percentage of scheduled study measurements that are actually collected	Through study completion, an average of 18 months
Secondary	Diaphragm function	Maximal diaphragm thickening fraction	Study day 7
Secondary	Changes in diaphragm thickness over time with or without neuromuscular blockade		First week of study