Acute Respiratory Distress SyndromeNCT02871102
Stress Index to Individualize Mechanical Ventilation in ARDS
A study testing Recruitment Maneuver with PEEP and Tidal Volume Optimization in people with Acute Respiratory Distress Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. 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?
- Recruitment Maneuver with PEEP and Tidal Volume Optimization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2017
- 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
- Admitted to the Intensive Care Unit
- Receiving invasive mechanical ventilation via endotracheal or tracheostomy tube
- Presence of ARDS by Berlin Criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a PaO2/FiO2 of <300 or SpO2/FiO2 <315)
Who cannot join
- Inability to obtain surrogate consent
- Presence of specified comorbidities:
- pregnancy
- pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented < 1L or baseline hypercapnia
- cerebral edema
- known intra-cranial abnormality
Show all 13Show fewer
- acute coronary syndrome
- Endotracheal or tracheostomy cuff leak
- Chest tube with persistent air leak
- Severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations)
- Presence of spontaneous respiratory activity as evidenced by examination of the ventilator waveform tracing
- Intrinsic PEEP of > 5 cmH2O
- Assessment of study staff or patient's attending physician that the patient would not be a good study participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP). Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible means to minimize ventilator-induced lung injury. This protocol aims to identify the range of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Recruitment Maneuver with PEEP and Tidal Volume Optimization
- Keywords
- mechanical ventilation, respiratory mechanics, acute respiratory distress syndrome, positive end-expiratory pressure, tidal volume
- 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.
Recruitment Maneuver with PEEP and Tidal Volume OptimizationProcedure or surgery
A staircase recruitment maneuver will be performed on pressure control ventilation followed by a decremental PEEP trial. During the decremental PEEP trial inspiratory tidal volumes will be varied at each step between 3 ml/kg and 10 ml/kg predicted body weight while recording the continuous pressure and flow tracings from the mechanical ventilator. With each PEEP and tidal volume combination, end expiratory and end-inspiratory plateau pressure and stress index will be assessed. At the completion of the decremental PEEP trial, the patient will be returned to ARDSnet-recommended ventilator settings.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Procedure: Recruitment Maneuver with PEEP and Tidal Volume Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ARDSnet-optimized and protocol-optimized tidal volume
Mean absolute difference between tidal volume in cc/kg PBW prescribed by ARDSnet settings on ARDSnet PEEP versus maximal protective tidal volume defined by stress index <1.05 at the ARDSnet PEEP on experimental protocol.
Measured: Completion of the study intervention, less than 1 day
Comparison of ARDSnet-optimized and protocol-optimized driving pressure
Mean difference in driving pressure prescribed by ARDSnet settings versus at lowest measured possible driving pressure that achieves equivalent minute ventilation as ARDSnet table with respiratory rate < or = 35 per minute and SI <1.05.
Measured: Completion of the study intervention, less than 1 day
Secondary outcomes (2)
Comparison of ARDSnet-optimized and protocol-optimized PEEP
Mean absolute difference between safest PEEP as determined by experimental protocol with tidal volume of 6 mL/kg PBW (defined as the PEEP at which 6 mL/kg PBW yields the lowest driving pressure with a SI <1.05) versus the PEEP established by ARDSnet table.
Measured: Completion of the study intervention, less than 1 day
Comparison of ARDSnet-optimized and protocol-optimized elastance
Mean difference in elastance prescribed by ARDSnet settings versus at lowest measured possible elastance achieving equivalent minute ventilation as ARDSnet table with respiratory rate < or = 35 per minute.
Measured: Completion of the study intervention, less than 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: The ART Trial was published suggesting harm by the intervention protocol, which was closely related to the protocol in this study, so the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew McKown, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871102
- Sponsor's protocol ID
- 160770
- Status last verified
- Jun 2018
- First submitted
- 10 Aug 2016
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McKown AC, Semler MW, Rice TW. Best PEEP trials are dependent on tidal volume. Crit Care. 2018 May 2;22(1):115. doi: 10.1186/s13054-018-2047-4.
PubMed 29720277
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
- ClinicalTrials.gov ID
- NCT02871102
- Acronym / sponsor ID
- 160770
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- mechanical ventilation, respiratory mechanics, acute respiratory distress syndrome, positive end-expiratory pressure, tidal volume
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ART Trial was published suggesting harm by the intervention protocol, which was closely related to the protocol in this study, so the study was terminated.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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.
Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP). Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible means to minimize ventilator-induced lung injury. This protocol aims to identify the range of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Procedure: Recruitment Maneuver with PEEP and Tidal Volume Optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the Intensive Care Unit
- Receiving invasive mechanical ventilation via endotracheal or tracheostomy tube
- Presence of ARDS by Berlin Criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a PaO2/FiO2 of <300 or SpO2/FiO2 <315)
Key exclusion criteria (13 listed)
- Inability to obtain surrogate consent
- Presence of specified comorbidities:
- Endotracheal or tracheostomy cuff leak
- Chest tube with persistent air leak
- Severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations)
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 |
|---|---|---|
| Recruitment Maneuver with PEEP and Tidal Volume OptimizationA staircase recruitment maneuver will be performed on pressure control ventilation followed by a decremental PEEP trial. During the decremental PEEP trial inspiratory tidal volumes will be varied at each step between 3 ml/kg and 10 ml/kg predicted body weight while recording the continuous pressure and flow tracings from the mechanical ventilator. With each PEEP and tidal volume combination, end expiratory and end-inspiratory plateau pressure and stress index will be assessed. At the completion of the decremental PEEP trial, the patient will be returned to ARDSnet-recommended ventilator settings. | Procedure or surgery | Intervention Arm |
Primary outcome
Comparison of ARDSnet-optimized and protocol-optimized tidal volume
Time frame: Completion of the study intervention, less than 1 day
Mean absolute difference between tidal volume in cc/kg PBW prescribed by ARDSnet settings on ARDSnet PEEP versus maximal protective tidal volume defined by stress index <1.05 at the ARDSnet PEEP on experimental protocol.
Comparison of ARDSnet-optimized and protocol-optimized driving pressure
Time frame: Completion of the study intervention, less than 1 day
Mean difference in driving pressure prescribed by ARDSnet settings versus at lowest measured possible driving pressure that achieves equivalent minute ventilation as ARDSnet table with respiratory rate < or = 35 per minute and SI <1.05.
2 secondary outcomes
Comparison of ARDSnet-optimized and protocol-optimized PEEP
Time frame: Completion of the study intervention, less than 1 day
Comparison of ARDSnet-optimized and protocol-optimized elastance
Time frame: Completion of the study intervention, less than 1 day
Results and safety
The study was stopped early (reason given: The ART Trial was published suggesting harm by the intervention protocol, which was closely related to the protocol in this study, so the study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Derived from this study: PubMed 29720277McKown AC, Semler MW, Rice TW. Best PEEP trials are dependent on tidal volume. Crit Care. 2018 May 2;22(1):115. doi: 10.1186/s13054-018-2047-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment Maneuver with PEEP and Tidal Volume Optimization in people with Acute Respiratory Distress Syndrome, run by Vanderbilt 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 3 inclusion and 13 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 7 Jun 2018. 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: The ART Trial was published suggesting harm by the intervention protocol, which was closely related to the protocol in this study, so the study was terminated.). 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?
Comparison of ARDSnet-optimized and protocol-optimized tidal volume (time frame: Completion of the study intervention, less than 1 day). 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?
On the ClinicalTrials.gov record for NCT02871102, which also lists 1 linked publication.
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 7 Jun 2018.