Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hennepin County Medical Center, Minneapolis | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a proof of concept study where the investigators aim to study the correlation between the use of a simple bedside ultrasound measurement of diaphragmatic muscle excursion with established (but time consuming) measurements made to optimize an important setting on the mechanical ventilator (positive end expiratory pressure or PEEP) in intubated adults with acute respiratory distress syndrome (ARDS) in the medical ICU.
Ventilator induced lung injury (VILI) generates morbidity and mortality in mechanically ventilated patients. The awareness of respiratory mechanics is essential in the prevention of VILI. Currently, plateau pressures are widely used as a guide to assess alveolar pressure and minimize alveolar injury. However, patients with reduced chest wall compliance can have higher plateau pressures that may not reflect true alveolar pressure. The transpulmonary pressure has been cited as the true alveolar driving pressure because it takes into account pleural pressure that reflect chest wall mechanics; however, this requires measurement of esophageal pressure.
The investigators have experienced a disproportionate degree of excursion between the posterior and anterior right hemidiaphragm on bedside ultrasound imaging in patients with ARDS, which may reflect the dependent atelectasis that occurs during low tidal volume ventilation, cardiac weight, weight of injured lung and accumulation of extravascular lung water in critically ill patients. The optimal PEEP can be guided by measurement of esophageal pressure (and subsequent calculation of transpulmonary distending pressure) with a balloon catheter placed into the esophagus much like a nasogastric tube for enteral access. The investigators believe that the normalization of the disproportionate degree of excursion between the anterior and posterior diaphragm can also be used to identify optimal PEEP, and may be correlated with changes in transpulmonary pressure (the current gold standard).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Diaphragmatic excursion ultrasound assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | This is a proof of concept study that investigates the degree of dorsal and ventral diaphragmatic excursion with bedside ultrasound during PEEP titration. Optimal PEEP management was guided by an esophageal probe calculating transthoracic pulmonary pressure. Each patient underwent a series of PEEP titrations for which data was recorded on diaphragm excursion (mm) and esophageal pressure (cmH2O). Diaphragm excursion (mm) was measured at the ventral and dorsal side using anatomic m-mode with bedside ultrasound. Esophageal pressure was measured using an esophageal probe which was placed at the bedside. | one year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Prekker, MD | Hennepin County Medical Center, Minneapolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31690616 | Derived | Cho RJ, Adams A, Ambur S, Lunos S, Shapiro R, Prekker ME. Ultrasound Assessment of Diaphragmatic Motion in Subjects With ARDS During Transpulmonary Pressure-Guided PEEP Titration. Respir Care. 2020 Mar;65(3):314-319. doi: 10.4187/respcare.06643. Epub 2019 Nov 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound | Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Ultrasound: Diaphragmatic excursion ultrasound assessment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound | Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Ultrasound: Diaphragmatic excursion ultrasound assessment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility | This is a proof of concept study that investigates the degree of dorsal and ventral diaphragmatic excursion with bedside ultrasound during PEEP titration. Optimal PEEP management was guided by an esophageal probe calculating transthoracic pulmonary pressure. Each patient underwent a series of PEEP titrations for which data was recorded on diaphragm excursion (mm) and esophageal pressure (cmH2O). Diaphragm excursion (mm) was measured at the ventral and dorsal side using anatomic m-mode with bedside ultrasound. Esophageal pressure was measured using an esophageal probe which was placed at the bedside. | We verify that all participants met the criteria and a total of 14 were enrolled. | Posted | Count of Participants | Participants | one year |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound | Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Ultrasound: Diaphragmatic excursion ultrasound assessment |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roy Cho, MD | University of Minnesota | 612-626-2637 | choxx548@umn.edu |
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
Not provided
Not provided
Not provided