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Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, PEEP, Critical Care Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound

Arm Description

Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2015
Last Updated
April 22, 2022
Sponsor
University of Minnesota
Collaborators
Hennepin County Medical Center, Minneapolis
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1. Study Identification

Unique Protocol Identification Number
NCT02463773
Brief Title
Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS
Official Title
Diaphragm Excursion By Ultrasound As Compared To Transpulmonary Pressure To Optimize PEEP In ARDS: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Hennepin County Medical Center, Minneapolis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Keywords
ARDS, PEEP, Critical Care Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Diaphragmatic excursion ultrasound assessment
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Prekker, MD
Organizational Affiliation
Hennepin County Medical Center, Minneapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31690616
Citation
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.
Results Reference
derived

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Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

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