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

NCT03132896 | Withdrawn

• 1 other identifier: 16-6360
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 6

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).

Conditions

Acute Respiratory Distress Syndrome; Diaphragm Injury; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (4)

• Study feasibility - number of participating centers

  The number of centers that participate in the study

  Through study completion, an average of 18 months

• 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

• 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

• Study feasibility - measurement acquisition rate

  Percentage of scheduled study measurements that are actually collected

  Through study completion, an average of 18 months

Secondary Outcomes (2)

• Diaphragm function

  Study day 7

• Changes in diaphragm thickness over time with or without neuromuscular blockade

  First week of study

Study Arms (1)

Patients with moderate or severe ARDS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe acute respiratory distress syndrome (ARDS) who consent to the ROSE trial will be invited to participate in the ROSETTA study.

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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (6)

Brigham and Women's Health

Boston, Massachusetts, 02115, United States

Location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ewan C Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 28, 2017
• Study Start: October 12, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (6)