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ARDS Esophageal Balloon Pressure Changes With Positioning Study

Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03120793
Enrollment
2
Registered
2017-04-19
Start date
2017-05-11
Completion date
2020-03-01
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Respiratory Failure

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.

Detailed description

The use of esophageal balloon catheters shows promise in improving outcomes of patients with severe ARDS. The estimation of pleural pressure (Ppl) has been validated in the upright position in humans with few studies commenting on the changes in supine positioning and almost none on prone positioning aside from radiographic analysis. An abstract presented at the annual American Thoracic Society meeting recently reported a series of 18 patients undergoing spinal surgery. In this population of patients without ARDS, esophageal pressure (Pes) decreased when shifting from supine to prone positioning. This suggests that transpleural pressure (PtmL) would be increased at a given airway pressure. The investigators hope to measure changes in PtmL in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed \>30 degrees), and prone positions. The esophageal balloon catheter will be placed using standard techniques and secured with tape to the patients' nares during changes in positioning. The goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

Interventions

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

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

will be patients who: * 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)

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Transmural pressure measurements from upright to prone positionMeasurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.Obtained from combination of esophageal balloon catheter measurements and mechanical ventilator in upright and prone positions
Change in Transmural pressure measurements from upright to supine positionThe patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.Obtained from esophageal balloon catheter measurements in upright and supine positions
Change in Airway pressure measurements from upright to prone positionMeasurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.Obtained from mechanical ventilator in prone and upright positions
Change in Airway pressure measurements from upright to supine positionThe patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.Obtained from mechanical ventilator in supine and upright positions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026