ARDS Esophageal Balloon Pressure Changes With Positioning Study

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03120793
• Other study ID #: 17-0135
• Status: Terminated
• Start date: May 11, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ARDS
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Esophageal balloon catheter
Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in Transmural pressure measurements from upright to prone position	Obtained from combination of esophageal balloon catheter measurements and mechanical ventilator in upright and prone positions	Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Secondary	Change in Transmural 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	Change in Airway pressure measurements from upright to prone position	Obtained from mechanical ventilator in prone and upright positions	Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Secondary	Change in Airway pressure measurements from upright to supine position	Obtained from mechanical ventilator in supine and upright positions	The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.