Trials Sponsors Conditions Drugs Pricing

Conditions

ARDS Respiratory Failure

Outcome Measures

Primary Outcomes (2)

Change in Esophageal pressure measurements from upright to prone position
Obtained from esophageal balloon catheter measurements in prone and upright positions
Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Change in Esophageal pressure measurements from upright to supine position
Obtained from esophageal balloon catheter measurements in upright and supine positions
The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.

Secondary Outcomes (4)

Change in Transmural pressure measurements from upright to prone position
Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Change in Transmural pressure measurements from upright to supine position
The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Change in Airway pressure measurements from upright to prone position
Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Change in Airway pressure measurements from upright to supine position
The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.

Study Arms (1)

Esophageal balloon catheter placement

This is the primary and only arm of the study in which acute respiratory distress syndrome patients will have an esophageal balloon catheter placed with pressures recorded in the supine, upright and prone positions

Device: Esophageal balloon catheter

Interventions

Esophageal balloon catheterDevice

Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions

Esophageal balloon catheter placement

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will be patients admitted to the medical intensive care unit with moderate to severe ARDS who are candidates for prone ventilation therapy and have no contraindications for the placement of an esophageal balloon catheter.

You may qualify if:

age at least 18 years old, need for mechanical ventilation, moderate or severe ARDS, and the ability to tolerate prone positioning.

Sponsors & Collaborators

University of North Carolina, Chapel Hill
Otherlead

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

Thomas Bice, MD, MS
UNC Pulmonology and Critical Care
PRINCIPAL INVESTIGATOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 19, 2017

Study Start

May 11, 2017

Actual (reported)

Study Stopped

ARDS Esophageal Balloon Pressure Changes With Positioning Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Esophageal balloon catheter placement

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Esophageal balloon catheter placement

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations