- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03132896
Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm (ROSETTA)
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Health
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Springfield, Massachusetts, Forente stater, 01199
- Baystate Health
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University Wexner Medical Center
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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:
- 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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Patients with moderate or severe ARDS
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Study feasibility - number of participating centers
Tidsramme: Through study completion, an average of 18 months
|
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
Tidsramme: Through study completion, an average of 18 months
|
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
Tidsramme: Through study completion, an average of 18 months
|
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
Tidsramme: Through study completion, an average of 18 months
|
Percentage of scheduled study measurements that are actually collected
|
Through study completion, an average of 18 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Diaphragm function
Tidsramme: Study day 7
|
Maximal diaphragm thickening fraction
|
Study day 7
|
Changes in diaphragm thickness over time with or without neuromuscular blockade
Tidsramme: First week of study
|
First week of study
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 16-6360
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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