Acute Respiratory Distress SyndromeARDSNCT03715751
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome
A study testing ASV and Lung Protective Ventilation in people with Acute Respiratory Distress Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. 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?
- ASV and Lung Protective Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 31 Jan 2021
- 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
- Patients ≥ 18 years of age
- Receiving mechanical ventilation in an intensive care unit
- ARDS, as defined by the Berlin definition:
- Hypoxemic respiratory failure with PaO2 / FiO2 ratio < 300 mmHg
- Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
- Respiratory failure not fully explained by cardiac failure or fluid overload
- Intubation on mechanical ventilation and receiving PEEP ≥ 5 cm H2O
- Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.
Who cannot join
- Clinical team refusal
- Esophageal injury or contraindication precluding placement of the esophageal balloon
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.
Read the detailed description
This study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and Adaptive Support Ventilation. The investigators will enroll adult patients with ARDS who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. Patient mechanics during each ventilation strategy will be compared before and after crossover.
After obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (Pao) and esophageal pressures (Pes), to estimate transpulmonary pressures (PL = Pao - Pes), while also measuring Flow and Volume. Use of esophageal balloon catheters is common practice in the ICUs, and standard of care at Beth Israel Deaconess Medical Center is to use these balloons in patients with ARDS. Both the respiratory therapy and physician staff are very comfortable with placement and use. The esophageal balloon will be left in place until extubation. If the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements.
Patients will then be randomized to be switched to ASV immediately or to be maintained on their current lung protective ventilation settings.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- ASV, Lung Protective Ventilation
- Keywords
- Adaptive Support Ventilation, ARDS, Esophageal Pressure, Mechanical Ventilation, Transpulmonary Pressure
- 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.
ASVOther
Also called Adaptive Support Ventilation
Adaptive Support Ventilation
Lung Protective VentilationOther
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.
| Study group | Role | What they receive |
|---|---|---|
| ASV | Active comparator | Patients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted to target the same minute ventilation achieved prior to any change in Vt. Patients will then be switched to ASV mode. The percentage minute volume (%minVol) will be adjusted to target the same minute ventilation as was achieved before the change. Settings will be maintained for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn. Receives: Other: ASV |
| Lung Protective Ventilation | Active comparator | Patients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted (while leaving the Vt at 6cc/kg) to achieve the same minute ventilation. Patients will then be maintained on their current lung protective ventilation settings for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn. Receives: Other: Lung Protective Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume
Lung tidal volume in both ventilation modes (mL)
Measured: Day 1
Secondary outcomes (15)
Driving Pressure (cmH20)
Driving pressure in both ventilation modes
Measured: Day 1
Respiratory rate (BPM)
Respiratory Rate in both ventilation modes
Measured: Day 1
Oxygenation (SpO2%)
Oxygenation (SpO2%) in both ventilation modes
Measured: Day 1
CO2 clearance
CO2 clearance in both ventilation modes
Measured: Day 1
Blood Gas pH
Blood Gas pH (units) in both ventilation modes
Measured: Day 1
Blood Gas Partial Pressure of Oxygen
Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes
Measured: Day 1
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)
Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes
Measured: Day 1
Composite measure (lung protectiveness) - Asynchrony index
Asynchrony index
Measured: Day 1
Composite measure (lung protectiveness) - Number of Adjustments
Number of Adjustments
Measured: Day 1
Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg
Time spent with tidal volumes less than or equal to 6cc/kg
Measured: Day 1
Composite measure (lung protectiveness) - Driving pressures less than 15
Time spent at or under Driving pressures less than 15
Measured: Day 1
Composite measure (lung protectiveness) - Plateau Pressure <30
Time spent at or under Plateau Pressure <30
Measured: Day 1
Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%
Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%
Measured: Day 1
Time to extubation
Time to liberation from mechanical ventilation (days)
Measured: 30 Days
ICU length of stay
Time to ICU discharge (days)
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start14 Feb 2018
- Primary completion2 Nov 2020
- Study completion31 Jan 2021
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 Beth Israel Deaconess Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Talmor, Beth Israel Deaconess Medical Center
- Investigators
- Daniel Talmor, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715751
- Sponsor's protocol ID
- 2017P000596
- Acronym
- ARDS
- Status last verified
- Mar 2022
- First submitted
- 15 Aug 2018
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Support Ventilation in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03715751
- Acronym / sponsor ID
- ARDS / 2017P000596
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Adaptive Support Ventilation, ARDS, Esophageal Pressure, Mechanical Ventilation, Transpulmonary Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Oct 2018 (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 purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.
Detailed description
This study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and Adaptive Support Ventilation. The investigators will enroll adult patients with ARDS who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. Patient mechanics during each ventilation strategy will be compared before and after crossover.
After obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (Pao) and esophageal pressures (Pes), to estimate transpulmonary pressures (PL = Pao - Pes), while also measuring Flow and Volume. Use of esophageal balloon catheters is common practice in the ICUs, and standard of care at Beth Israel Deaconess Medical Center is to use these balloons in patients with ARDS. Both the respiratory therapy and physician staff are very comfortable with placement and use. The esophageal balloon will be left in place until extubation. If the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements.
Patients will then be randomized to be switched to ASV immediately or to be maintained on their current lung protective ventilation settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASV | Active comparator | Other: ASVPatients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted to target the same minute ventilation achieved prior to any change in Vt. Patients will then be switched to ASV mode. The percentage minute volume (%minVol) will be adjusted to target the same minute ventilation as was achieved before the change. Settings will be maintained for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn. |
| Lung Protective Ventilation | Active comparator | Other: Lung Protective VentilationPatients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted (while leaving the Vt at 6cc/kg) to achieve the same minute ventilation. Patients will then be maintained on their current lung protective ventilation settings for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years of age
- Receiving mechanical ventilation in an intensive care unit
- ARDS, as defined by the Berlin definition:
- Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.
Key exclusion criteria (2 listed)
- Clinical team refusal
- Esophageal injury or contraindication precluding placement of the esophageal balloon
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 |
|---|---|---|
| ASVAlso: Adaptive Support VentilationAdaptive Support Ventilation | Other | ASV |
| Lung Protective VentilationTargeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines. | Other | Lung Protective Ventilation |
Primary outcome
Tidal Volume
Time frame: Day 1
Lung tidal volume in both ventilation modes (mL)
15 secondary outcomes
Driving Pressure (cmH20)
Time frame: Day 1
Respiratory rate (BPM)
Time frame: Day 1
Oxygenation (SpO2%)
Time frame: Day 1
CO2 clearance
Time frame: Day 1
Blood Gas pH
Time frame: Day 1
Blood Gas Partial Pressure of Oxygen
Time frame: Day 1
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)
Time frame: Day 1
Composite measure (lung protectiveness) - Asynchrony index
Time frame: Day 1
Composite measure (lung protectiveness) - Number of Adjustments
Time frame: Day 1
Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg
Time frame: Day 1
Composite measure (lung protectiveness) - Driving pressures less than 15
Time frame: Day 1
Composite measure (lung protectiveness) - Plateau Pressure <30
Time frame: Day 1
Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%
Time frame: Day 1
Time to extubation
Time frame: 30 Days
ICU length of stay
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Talmor, MD, MPH principal investigator
Beth Israel Deaconess 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 ASV and Lung Protective Ventilation in people with Acute Respiratory Distress Syndrome, run by Beth Israel Deaconess Medical Center 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 8 inclusion and 2 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 8 Mar 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tidal Volume (time frame: Day 1). 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 8 Mar 2022.