Acute Respiratory Distress SyndromeROSETTANCT03132896
Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm
An observational study of Acute Respiratory Distress Syndrome and Diaphragm Injury, run by University Health Network, Toronto at 6 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Diaphragm Injury, Neuromuscular Blockade
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Oct 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brigham and Women's Health
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Vanderbilt University
Nashville, Tennessee, 37232
Oregon Health & Science University
Portland, Oregon, 97239
Baystate Health
Springfield, Massachusetts, 01199
About this study
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).
Read the 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:
- Test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation;
- Determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome; and
- Evaluate whether patients with greater diaphragm dysfunction exhibit worse functional outcomes compared to patients without diaphragm dysfunction.
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with moderate or severe ARDS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility - number of participating centers
The number of centers that participate in the study
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Study feasibility - measurement acquisition rate
Percentage of scheduled study measurements that are actually collected
Measured: Through study completion, an average of 18 months
Secondary outcomes (2)
Diaphragm function
Maximal diaphragm thickening fraction
Measured: Study day 7
Changes in diaphragm thickness over time with or without neuromuscular blockade
Measured: First week of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start12 Oct 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: Investigational device no longer has Health Canada approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewan C Goligher, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132896
- Sponsor's protocol ID
- 16-6360
- Acronym
- ROSETTA
- Status last verified
- Jul 2018
- First submitted
- 19 Apr 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm
- ClinicalTrials.gov ID
- NCT03132896
- Acronym / sponsor ID
- ROSETTA / 16-6360
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigational device no longer has Health Canada approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation;
- Determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome; and
- Evaluate whether patients with greater diaphragm dysfunction exhibit worse functional outcomes compared to patients without diaphragm dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate or severe ARDS | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study feasibility - number of participating centers
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 18 months
Percentage of scheduled study measurements that are actually collected
2 secondary outcomes
Diaphragm function
Time frame: Study day 7
Changes in diaphragm thickness over time with or without neuromuscular blockade
Time frame: First week of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewan C Goligher, MD, PhD principal investigator
University Health Network, Toronto
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Diaphragm Injury, run by University Health Network, Toronto at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility - number of participating centers (time frame: Through study completion, an average of 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.