Acute Respiratory Distress SyndromeNCT05675696
Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
A study testing Esophageal Catheter in people with Acute Respiratory Distress Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Esophageal Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to 1 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
- Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
- Triggering breaths on the ventilator
- Treating medical team agrees with patient participation
Who cannot join
- Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
- Shock that requires ≥ 2 vasopressors
- pH on arterial blood gas ≤7.25
- Minute ventilation ≥ 14L/min
- Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
- Severe ARDS with P/F ratio <60
Show all 11Show fewer
- Pregnancy
- Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
- Decision to withhold life-sustaining treatment
- Patients who are not expected to survive for 24 hours
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Esophageal Catheter
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal CatheterOther
Also called PulmoTech Esophageal Pressure System (iEPS)
Newly designed external monitor that will capture esophageal pressure from a proprietary nasogastric tube combined with simultaneous pressure, flow, and volume measurements from the ventilator tubing.
| Study group | Role | What they receive |
|---|---|---|
| ARDS Patients Intubated on Mechanical Ventilation | Experimental | ARDS patients in the ICU who are intubated on mechanical ventilation will be included. During ventilation, an esophageal catheter will be used to measure the esophageal pressure, which estimates pleural pressure at the level of the catheter. The esophageal catheter's position will be confirmed by a chest radiograph once inserted. The ventilator settings may be changed to see if these ventilator adjustments can reduce potential lung stress in ARDS patients. There is no set criteria for adjusting the ventilator settings based on the study device, but the goal would be to adjust the volume until the inspiratory effort measured by the catheter disappears so as to protect the patient. A one-to-two-hour study session will be performed for data collection. The esophageal catheter will be removed at the end of the study session or can be left in place for use as a feeding tube if needed for patient care. Receives: Other: Esophageal Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary Driving Pressure
Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.
Measured: Up to Hour 2 (Day 1)
Driving Pressure
Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.
Measured: Up to Hour 2 (Day 1)
Work of Breathing (WOB)
WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.
Measured: Up to Hour 2 (Day 1)
Pressure-Time Product (PTP)
PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.
Measured: Up to Hour 2 (Day 1)
Secondary outcomes (5)
Lung Compliance (C, l)
Lung compliance is calculated as the tidal volume divided by the difference of transpulmonary pressure at end inspiration minus transpulmonary pressure at PEEP:
(C, l) = tidal volume/(transpulmonary pressure at end inspiration - transpulmonary pressure at PEEP).
Expressed in (ml/cmH2O).
Measured: Up to Hour 2 (Day 1)
Chest Wall Compliance (C, cw)
Chest wall compliance is calculated as the tidal volume divided by the difference of esophageal pressure at end inspiration minus esophageal pressure at PEEP:
(C, cw) = tidal volume/(esophageal pressure at end inspiration - esophageal pressure at PEEP).
Expressed in (ml/cmH2O).
Measured: Up to Hour 2 (Day 1)
Respiratory System Compliance (C, rs)
Respiratory System Compliance is calculated as the tidal volume divided by the difference of the airway pressure at end inspiration minus airway pressure at PEEP:
(C, rs) = tidal volume/(airway pressure at end inspiration - airway pressure at PEEP).
Expressed in (ml/cmH2O).
Measured: Up to Hour 2 (Day 1)
Oxygen Saturation
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
Measured: Up to Hour 2 (Day 1)
PaO2/FiO2 (P/F) Ratio
The P/F ratio is the arterial partial pressure of oxygen (PaO2) divided by the inspired oxygen concentration (FiO2).
Measured: Up to Hour 2 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study startOct 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: The company that was providing the catheters lost funding, and the study will not be moving forward.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beno Oppenheimer, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675696
- Sponsor's protocol ID
- 22-00695
- Status last verified
- Apr 2025
- First submitted
- 29 Dec 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Beno Oppenheimer \[Beno.Oppenheimer@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05675696
- Acronym / sponsor ID
- 22-00695
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company that was providing the catheters lost funding, and the study will not be moving forward.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 9 Jan 2023 (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 present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS Patients Intubated on Mechanical Ventilation | Experimental | Other: Esophageal CatheterARDS patients in the ICU who are intubated on mechanical ventilation will be included. During ventilation, an esophageal catheter will be used to measure the esophageal pressure, which estimates pleural pressure at the level of the catheter. The esophageal catheter's position will be confirmed by a chest radiograph once inserted. The ventilator settings may be changed to see if these ventilator adjustments can reduce potential lung stress in ARDS patients. There is no set criteria for adjusting the ventilator settings based on the study device, but the goal would be to adjust the volume until the inspiratory effort measured by the catheter disappears so as to protect the patient. A one-to-two-hour study session will be performed for data collection. The esophageal catheter will be removed at the end of the study session or can be left in place for use as a feeding tube if needed for patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
- Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
- Triggering breaths on the ventilator
- Treating medical team agrees with patient participation
Key exclusion criteria (11 listed)
- Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
- Shock that requires ≥ 2 vasopressors
- pH on arterial blood gas ≤7.25
- Minute ventilation ≥ 14L/min
- Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
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 CatheterAlso: PulmoTech Esophageal Pressure System (iEPS)Newly designed external monitor that will capture esophageal pressure from a proprietary nasogastric tube combined with simultaneous pressure, flow, and volume measurements from the ventilator tubing. | Other | ARDS Patients Intubated on Mechanical Ventilation |
Primary outcome
Transpulmonary Driving Pressure
Time frame: Up to Hour 2 (Day 1)
Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.
Driving Pressure
Time frame: Up to Hour 2 (Day 1)
Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.
Work of Breathing (WOB)
Time frame: Up to Hour 2 (Day 1)
WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.
Pressure-Time Product (PTP)
Time frame: Up to Hour 2 (Day 1)
PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.
5 secondary outcomes
Lung Compliance (C, l)
Time frame: Up to Hour 2 (Day 1)
Chest Wall Compliance (C, cw)
Time frame: Up to Hour 2 (Day 1)
Respiratory System Compliance (C, rs)
Time frame: Up to Hour 2 (Day 1)
Oxygen Saturation
Time frame: Up to Hour 2 (Day 1)
PaO2/FiO2 (P/F) Ratio
Time frame: Up to Hour 2 (Day 1)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Beno Oppenheimer [Beno.Oppenheimer@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Beno Oppenheimer, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal Catheter in people with Acute Respiratory Distress Syndrome, run by NYU Langone Health 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 9 Apr 2025. 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 withdrawn before enrolling participants, so there are no results.
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?
Transpulmonary Driving Pressure (time frame: Up to Hour 2 (Day 1)). The study lists 4 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 9 Apr 2025.