Acute Respiratory FailureASOPNCT05125952
Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
A study testing Viasys Avea Ventilator, Philips Respironics NM3 device and Servo U ventilator in people with Acute Respiratory Failure and Mechanical Ventilation Complication, run by Duke University at 1 site in United States.
Trial summary
ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- What is being tested?
- Viasys Avea Ventilator, Philips Respironics NM3 device and Servo U ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
- Managed in pressure-support mode of ventilation
Who cannot join
- Actively undergoing a spontaneously awakening trial or SAT
- Patient or surrogate is unable to provide informed consent
- Currently pregnant
- Currently incarcerated
- Acute exacerbation of an obstructive lung disease
- Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
- Esophageal, gastric or duodenal surgical procedures within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.
Read the detailed description
Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI.
Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV.
Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.
- Conditions
- Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- Being tested
- Viasys Avea Ventilator, Philips Respironics NM3 device, Servo U ventilator, Vyaire SmartCath adult nasogastric tube with Esophageal balloon
- Keywords
- Self-induced lung injury, Pressure-support ventilation
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viasys Avea VentilatorDevice
Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath.
Philips Respironics NM3 deviceDevice
Measuring static airway driving pressure during pressure support breath
Servo U ventilatorDevice
Measuring static airway driving pressure and p0.1 during pressure support breath.
Vyaire SmartCath adult nasogastric tube with Esophageal balloonDevice
Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Acute Respiratory Failure | Experimental | Patients with acute respiratory failure managed with pressure-support ventilation. Receives: Device: Viasys Avea Ventilator; Device: Philips Respironics NM3 device; Device: Servo U ventilator; Device: Vyaire SmartCath adult nasogastric tube with Esophageal balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo)
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Measured: Study day 1
Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3)
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Measured: Study day 1
Airway Occlusion Test (AOC)
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver.
Measured: Study day 1
Respiratory System Driving Pressure Measured During Volume Control Breath.
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Measured: Study day 1
Transpulmonary Driving Pressure Measured During Volume Control Breath.
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
Measured: Study day 1
Secondary outcomes (5)
Duration of Mechanical Ventilation
Number of days receiving mechanical ventilation
Measured: Index hospitalization (up to 28 days)
Duration of Intensive Care Unit Admission
Number of days admitted to intensive care unit
Measured: Index hospitalization (up to 28 days)
Duration of Hospital Admission
Number of days admitted to hospital
Measured: Index hospitalization (up to 28 days)
Ventilator Free Days
Number of days free from mechanical ventilation
Measured: Index hospitalization (up to 28 days)
In-hospital Survival
Survival to discharge
Measured: Index hospitalization (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start8 Feb 2022
- Primary completion21 Nov 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil R MacIntyre, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125952
- Sponsor's protocol ID
- Pro00106860
- Acronym
- ASOP
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2021
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.
PubMed 27842744Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
PubMed 24283226Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.
PubMed 33381233Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.
PubMed 30871304Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6.
PubMed 15691390Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
PubMed 27334266
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
- ClinicalTrials.gov ID
- NCT05125952
- Acronym / sponsor ID
- ASOP / Pro00106860
- Conditions
- Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- Keywords
- Self-induced lung injury, Pressure-support ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.
Detailed description
Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI.
Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV.
Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Failure | Experimental | Device: Viasys Avea Ventilator, Device: Philips Respironics NM3 device, Device: Servo U ventilator, Device: Vyaire SmartCath adult nasogastric tube with Esophageal balloonPatients with acute respiratory failure managed with pressure-support ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
- Managed in pressure-support mode of ventilation
Key exclusion criteria (7 listed)
- Actively undergoing a spontaneously awakening trial or SAT
- Patient or surrogate is unable to provide informed consent
- Currently pregnant
- Currently incarcerated
- Acute exacerbation of an obstructive lung disease
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 |
|---|---|---|
| Viasys Avea VentilatorMeasuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath. | Device | Acute Respiratory Failure |
| Philips Respironics NM3 deviceMeasuring static airway driving pressure during pressure support breath | Device | Acute Respiratory Failure |
| Servo U ventilatorMeasuring static airway driving pressure and p0.1 during pressure support breath. | Device | Acute Respiratory Failure |
| Vyaire SmartCath adult nasogastric tube with Esophageal balloonMeasuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver. | Device | Acute Respiratory Failure |
Primary outcome
Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo)
Time frame: Study day 1
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3)
Time frame: Study day 1
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Airway Occlusion Test (AOC)
Time frame: Study day 1
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver.
Respiratory System Driving Pressure Measured During Volume Control Breath.
Time frame: Study day 1
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Transpulmonary Driving Pressure Measured During Volume Control Breath.
Time frame: Study day 1
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
5 secondary outcomes
Duration of Mechanical Ventilation
Time frame: Index hospitalization (up to 28 days)
Duration of Intensive Care Unit Admission
Time frame: Index hospitalization (up to 28 days)
Duration of Hospital Admission
Time frame: Index hospitalization (up to 28 days)
Ventilator Free Days
Time frame: Index hospitalization (up to 28 days)
In-hospital Survival
Time frame: Index hospitalization (up to 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27842744Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.
- Background: PubMed 24283226Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
- Background: PubMed 33381233Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.
- Background: PubMed 30871304Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.
- Background: PubMed 15691390Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6.
- Background: PubMed 27334266Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
- 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.
Neil R MacIntyre, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viasys Avea Ventilator, Philips Respironics NM3 device and Servo U ventilator in people with Acute Respiratory Failure and Mechanical Ventilation Complication, run by Duke University 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 2 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: finished, as of the sponsor's last update on 15 Oct 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?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) (time frame: Study day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05125952, which also lists 6 linked publications.
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 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.