ARDSNCT03120793
ARDS Esophageal Balloon Pressure Changes With Positioning Study
An observational study of ARDS and Respiratory Failure, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Respiratory Failure
- What is being tested?
- Esophageal balloon catheter
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age at least 18 years old, need for mechanical ventilation, moderate or severe ARDS, and the ability to tolerate prone positioning.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation
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.
Read the 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.
- Conditions
- ARDS, Respiratory Failure
- Being tested
- Esophageal balloon catheter
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal balloon catheterDevice
Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Esophageal balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Esophageal pressure measurements from upright to prone position
Obtained from esophageal balloon catheter measurements in prone and upright positions
Measured: 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
Measured: 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
Obtained from combination of esophageal balloon catheter measurements and mechanical ventilator in upright and prone positions
Measured: 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
Obtained from esophageal balloon catheter measurements in upright and supine positions
Measured: 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
Obtained from mechanical ventilator in prone and upright positions
Measured: 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
Obtained from mechanical ventilator in supine and upright positions
Measured: The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start11 May 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Failure to recruit/enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Bice, MD, MS, Principal investigator, UNC Pulmonology and Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120793
- Sponsor's protocol ID
- 17-0135
- Status last verified
- Jan 2021
- First submitted
- 20 Mar 2017
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03120793
- Acronym / sponsor ID
- 17-0135
- Conditions
- ARDS, Respiratory Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failure to recruit/enroll
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal balloon catheter placement | – | Device: Esophageal balloon catheterThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- age at least 18 years old, need for mechanical ventilation, moderate or severe ARDS, and the ability to tolerate prone positioning.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal balloon catheterMeasurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions | Device | Esophageal balloon catheter placement |
Primary outcome
Change in Esophageal pressure measurements from upright to prone position
Time frame: Measurements 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 position
Time frame: The 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
4 secondary outcomes
Change in Transmural pressure measurements from upright to prone position
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Results and safety
The study was stopped early (reason given: Failure to recruit/enroll). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bice, MD, MS principal investigator
UNC Pulmonology and Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Respiratory Failure, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit/enroll). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Esophageal pressure measurements from upright to prone position (time frame: Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021; AzTrials last refreshed its copy on 27 Oct 2026.