ARDSGENIE-VentNCT05708365
Generating Evidence in ECMO Ventilation Strategies
A study testing Standard-Lung Protective Ventilation and Ultra-Lung Protective Ventilation in people with ARDS and Acute Respiratory Failure, run by Duke University at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Acute Respiratory Failure
- What is being tested?
- Standard-Lung Protective Ventilation and Ultra-Lung Protective Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 25 Aug 2024
- 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
- All patients being treated with ECMO in the Duke University Hospital Medical ICU will be eligible
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Generating Evidence in ECMO Ventilation Strategies - A Pilot Study
The goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. The main questions it aims to answer are:
- will clinicians closely follow different ICU ventilator protocols
- will different ICU ventilator protocols change the way that patients are treated.
Participants will be assigned to one of two ventilator protocols based on the month that they are first started on ECMO. Researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.
Read the detailed description
This is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of ICU-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ECMO). The overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. The investigators will do this by completion of the following aims:
Aim 1: Measure clinician fidelity to ICU-level ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Clinicians will have high fidelity to ICU-level ventilator management protocols for patients with severe ARDS on ECMO. To test this hypothesis, the investigators will conduct a pilot cluster-crossover study. The Duke medical ICU will be treated as a single cluster of patients. This cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ECMO, and then crossover to an ultra-lung protective ventilation protocol. The investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. The proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility.
Aim 2: Explore the clinical impact of using different ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Patients managed with standard lung protective ventilation will have shorter durations of ECMO and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. To test this hypothesis, the investigators will measure the duration of ECMO and mechanical ventilation for all patients enrolled in the study. The investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.
- Conditions
- ARDS, Acute Respiratory Failure
- Being tested
- Standard-Lung Protective Ventilation, Ultra-Lung Protective Ventilation
- Keywords
- extracorporeal membrane oxygenation, mechanical ventilation, lung protective ventilation, ultra-lung protective ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-Lung Protective VentilationOther
ICU ventilator protocol adhering to the following lung protective ventilation strategy:
- Plateau Pressure ≤ 30 cm of water
- PEEP and FiO2 set according to ARDSnet table
- Driving Pressure ≤ 15 cm of water
- Respiratory rate between 8 and 30 breaths per minute
Ultra-Lung Protective VentilationOther
ICU ventilator protocol adhering to the following lung protective ventilation strategy:
- Plateau Pressure ≤ 30 cm of water
- PEEP and FiO2 set according to ARDSnet table
- Driving Pressure ≤ 15 cm of water
- Respiratory rate between 8 and 30 breaths per minute
| Study group | Role | What they receive |
|---|---|---|
| Standard-Lung Protective Ventilation | Active comparator | Not described Receives: Other: Ultra-Lung Protective Ventilation |
| Ultra-Lung Protective Ventilation | Active comparator | Not described Receives: Other: Standard-Lung Protective Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol fidelity rate
Percentage of days that a patient's ventilator settings adhere to assigned protocol
Measured: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
Secondary outcomes (7)
Duration of ECMO
Total number of days a patient is supported with ECMO
Measured: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
Duration of mechanical ventilation
Total number of days a patient is supported with mechanical ventilation
Measured: From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks
Duration of ICU admission
Total number of days a patient is cared for in the ICU
Measured: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Duration of Hospital admission
Total number of days patient is admitted to the hospital
Measured: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Survival to discharge
Whether a patient survives until hospital discharge
Measured: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Time to meeting criteria for ECMO weaning
Total number of days between enrollment and when a patient meets criteria for ECMO weaning
Measured: From study enrollment until meeting weaning criteria or death, whichever comes first, up to 52 weeks
Time to first ECMO weaning trial
Total number of days between enrollment and when a patient first has an ECMO weaning trial
Measured: From study enrollment until first weaning trial or death, whichever comes first, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Mar 2023
- Primary completion21 Jul 2024
- Study completion25 Aug 2024
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias H Pratt, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708365
- Sponsor's protocol ID
- Pro00110840
- Acronym
- GENIE-Vent
- Status last verified
- Jun 2024
- First submitted
- 13 Jan 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Evidence in ECMO Ventilation Strategies - A Pilot Study
- ClinicalTrials.gov ID
- NCT05708365
- Acronym / sponsor ID
- GENIE-Vent / Pro00110840
- Conditions
- ARDS, Acute Respiratory Failure
- Keywords
- extracorporeal membrane oxygenation, mechanical ventilation, lung protective ventilation, ultra-lung protective ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 1 Feb 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 goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. The main questions it aims to answer are:
- will clinicians closely follow different ICU ventilator protocols
- will different ICU ventilator protocols change the way that patients are treated.
Participants will be assigned to one of two ventilator protocols based on the month that they are first started on ECMO. Researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.
Detailed description
This is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of ICU-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ECMO). The overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. The investigators will do this by completion of the following aims:
Aim 1: Measure clinician fidelity to ICU-level ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Clinicians will have high fidelity to ICU-level ventilator management protocols for patients with severe ARDS on ECMO. To test this hypothesis, the investigators will conduct a pilot cluster-crossover study. The Duke medical ICU will be treated as a single cluster of patients. This cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ECMO, and then crossover to an ultra-lung protective ventilation protocol. The investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. The proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility.
Aim 2: Explore the clinical impact of using different ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Patients managed with standard lung protective ventilation will have shorter durations of ECMO and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. To test this hypothesis, the investigators will measure the duration of ECMO and mechanical ventilation for all patients enrolled in the study. The investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-Lung Protective Ventilation | Active comparator | Other: Ultra-Lung Protective Ventilation |
| Ultra-Lung Protective Ventilation | Active comparator | Other: Standard-Lung Protective Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients being treated with ECMO in the Duke University Hospital Medical ICU will be eligible
Key exclusion criteria (1 listed)
- There are no exclusion criteria
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 |
|---|---|---|
| Standard-Lung Protective VentilationICU ventilator protocol adhering to the following lung protective ventilation strategy: * Plateau Pressure ≤ 30 cm of water * PEEP and FiO2 set according to ARDSnet table * Driving Pressure ≤ 15 cm of water * Respiratory rate between 8 and 30 breaths per minute | Other | Ultra-Lung Protective Ventilation |
| Ultra-Lung Protective VentilationICU ventilator protocol adhering to the following lung protective ventilation strategy: * Plateau Pressure ≤ 30 cm of water * PEEP and FiO2 set according to ARDSnet table * Driving Pressure ≤ 15 cm of water * Respiratory rate between 8 and 30 breaths per minute | Other | Standard-Lung Protective Ventilation |
Primary outcome
Protocol fidelity rate
Time frame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
Percentage of days that a patient's ventilator settings adhere to assigned protocol
7 secondary outcomes
Duration of ECMO
Time frame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
Duration of mechanical ventilation
Time frame: From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks
Duration of ICU admission
Time frame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Duration of Hospital admission
Time frame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Survival to discharge
Time frame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Time to meeting criteria for ECMO weaning
Time frame: From study enrollment until meeting weaning criteria or death, whichever comes first, up to 52 weeks
Time to first ECMO weaning trial
Time frame: From study enrollment until first weaning trial or death, whichever comes first, up to 52 weeks
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 21 Nov 2024.
- 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.
Elias H Pratt, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-Lung Protective Ventilation and Ultra-Lung Protective Ventilation in people with ARDS and Acute Respiratory Failure, 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 1 inclusion and 1 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 21 Nov 2024. 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?
Protocol fidelity rate (time frame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks). 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 21 Nov 2024.