ARDS Esophageal Balloon Pressure Changes With Positioning Study

NCT03120793 | Terminated FDA Device

• 1 other identifier: 17-0135
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The use of esophageal balloon catheters, which use esophageal pressure as a surrogate measurement for transpleural pressure, shows promise in improving outcomes of patients with severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilator. The investigators hope to measure changes in in transpleural pressures in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed \>30 degrees), and prone positions. The goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

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 catheter DEVICE

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

Esophageal balloon catheter placement

Eligibility Criteria

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

You may not qualify if:

• are deemed too ill by their clinicians to be included in the study
• have esophageal or nasopharyngeal pathology (such as tumors, sinusitis, epistaxis, ulcerations, recent surgery or bleeding varices) preventing insertion of the esophageal balloon catheter
• diverticulitis
• bronchopulmonary fistula
• solid-organ transplantation
• history of difficult intubation or airway management
• or contraindications to prone positioning (per the UNC Medical Intensive Care Unit Pronation Therapy protocol, attached)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Thomas Bice, MD, MS

  UNC Pulmonology and Critical Care

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)