Acute Respiratory Distress SyndromeNCT02463773
Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS
A study testing Ultrasound in people with Acute Respiratory Distress Syndrome and Acute Respiratory Failure, run by University of Minnesota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.
Who cannot join
- Any contraindication for nasogastric tube placement including recent injury or pathologic condition of the esophagus.
- Major bronchopleural fistula.
- Solid organ transplant recipient.
- History or current diagnosis of diaphragmatic paralysis.
- Non-conventional mechanical ventilation strategy including high frequency oscillation, airway pressure release ventilation, prone ventilation and extra- corporeal membrane oxygenation.
- Hemodynamic instability defined as MAP<65 with multiple vasopressors.
- Declining to sign consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Diaphragm Excursion By Ultrasound As Compared To Transpulmonary Pressure To Optimize PEEP In ARDS: A Pilot Study
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.
Read the detailed description
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).
- Being tested
- Ultrasound
- Keywords
- ARDS, PEEP, Critical Care Ultrasound
- 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.
UltrasoundDevice
Diaphragmatic excursion ultrasound assessment
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis
- Responsible party
- Sponsor
- Investigators
- Matthew Prekker, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463773
- Sponsor's protocol ID
- G5252
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2015
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31690616
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Excursion By Ultrasound As Compared To Transpulmonary Pressure To Optimize PEEP In ARDS: A Pilot Study
- ClinicalTrials.gov ID
- NCT02463773
- Acronym / sponsor ID
- G5252
- Keywords
- ARDS, PEEP, Critical Care Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: UltrasoundAdults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.
Key exclusion criteria (7 listed)
- Any contraindication for nasogastric tube placement including recent injury or pathologic condition of the esophagus.
- Major bronchopleural fistula.
- Solid organ transplant recipient.
- History or current diagnosis of diaphragmatic paralysis.
- Non-conventional mechanical ventilation strategy including high frequency oscillation, airway pressure release ventilation, prone ventilation and extra- corporeal membrane oxygenation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundDiaphragmatic excursion ultrasound assessment | Device | Ultrasound |
Primary outcome
Feasibility
Time frame: one year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31690616Cho 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.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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.
Matthew Prekker, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Acute Respiratory Distress Syndrome and Acute Respiratory Failure, run by University of Minnesota at 1 site 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 7 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: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 17 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463773, which also lists 1 linked publication.
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 17 May 2022.