Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

NCT02463773 | Completed Results DMC

• 1 other identifier: G5252
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Keywords

ARDS; PEEP; Critical Care Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ultrasound

EXPERIMENTAL

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

Device: Ultrasound

Interventions

Ultrasound DEVICE

Diaphragmatic excursion ultrasound assessment

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Hennepin County Medical Center, Minneapolis: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 31690616 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Roy Cho, MD
• Organization: University of Minnesota

choxx548@umn.edu

612-626-2637

Study Officials

• Matthew Prekker, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-04

Locations

US (1)