Clinical trial NCT03132896: Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm
Official title: Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Respiratory Distress Syndrome
Diaphragm Injury
Neuromuscular Blockade
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Study feasibility - number of participating centers
timeFrame: Through study completion, an average of 18 months
measure: Study feasibility - number of trained sonographers in study
timeFrame: Through study completion, an average of 18 months
measure: Study feasibility - enrolment rate
timeFrame: Through study completion, an average of 18 months
measure: Study feasibility - measurement acquisition rate
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
measure: Diaphragm function
timeFrame: Study day 7
measure: Changes in diaphragm thickness over time with or without neuromuscular blockade
timeFrame: First week of study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Health
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University Health Network, Toronto
name: Ewan C Goligher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: