New Ventilator for Lung Health

Overseen By Nick Ingraham, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Opted out, ECMO, Elective surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new ventilator strategy, ADHERE-LPV, to improve lung health in patients requiring mechanical ventilation. The goal is to determine if altering default ventilator settings in hospital systems can lead to better patient outcomes. Patients needing a ventilator for more than 12 hours and who have not undergone elective surgery may qualify for this study. The trial compares current ventilator methods with a new hospital approach to identify the most effective strategy. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future ventilator care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ventilator is safe for lung health?

Research has shown that lung-protective ventilation (LPV) methods are safe and beneficial for patients requiring mechanical ventilation. Studies have found that LPV can improve health outcomes, particularly for individuals with severe lung conditions like acute respiratory distress syndrome (ARDS).

In past studies, only about 40% of patients received LPV as recommended, but those who did often experienced better recovery. Safety data indicate that when used correctly, LPV is generally well-tolerated and does not cause major side effects.

The new ventilator in this trial aims to enhance the use of these safe LPV methods by automatically adjusting settings through the hospital's electronic systems. This should enable more patients to benefit from LPV without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new ventilator protocol, ADHERE-LPV, because it offers a fresh approach to mechanical ventilation for patients with lung issues. Unlike the standard ventilators, which follow conventional settings across health systems, this experimental ventilator uses a novel ventilation order that could potentially improve lung health. The unique aspect is its tailored settings, designed to better match individual patient needs, which might lead to more effective and safer respiratory support. This innovation could enhance patient outcomes and reduce complications associated with standard mechanical ventilation methods.

What evidence suggests that this ventilator is effective for lung health?

Research has shown that lung-protective ventilation (LPV) can improve outcomes for patients on breathing machines. LPV involves using smaller breaths to prevent lung damage, and studies have found it particularly beneficial for those with severe lung conditions like acute respiratory distress syndrome (ARDS). For instance, one study found that following LPV reduced complications and increased survival rates. This trial will compare the new experimental ventilator, ADHERE-LPV, which incorporates LPV principles, with the standard of care ventilator. Adopting LPV more closely in hospital practices has improved patient care. Overall, evidence strongly supports LPV as a beneficial approach for lung health in patients on mechanical ventilation. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

The ADHERE-LPV trial is for adults aged 18 and over who require mechanical ventilation. It's designed to test if a new strategy in hospitals can improve the use of lung-protective ventilation (LPV) techniques.

Inclusion Criteria

Requires mechanical ventilation

I am 18 years old or older.

Exclusion Criteria

The mode ordered does not require a set tidal volume

Requires ECMO prior to ICU admission

Data during the use of ECMO

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of an EHR-based strategy to enhance adherence to lung-protective ventilation for a 9-month period

9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADHERE-LPV

Trial Overview This study compares patient outcomes using two different ventilators: a new one with an EHR-based strategy promoting LPV, versus a control ventilator without this feature. Hospitals are randomly chosen to use either the new or control ventilator.

How Is the Trial Designed?

Group I: Experimental Ventilator Experimental Treatment 1 Intervention

Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order

Group II: Standard of Care Ventilator Active Control 1 Intervention

Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to the current ventilator order that is used across the health system.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11129028/

Quality improvement project to improve adherence to lung ... Lung protective ventilation (LPV) is advocated for all patients requiring mechanical ventilation (MV), for any duration of time, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03698799

Adherence to LPV in SICU and Associated Clinical Outcomes The primary outcome of this study is to determine the adherence rate to the LPV strategy at the initiation of MV support in mechanically ventilated patients in ...

3. journals.lww.com journals.lww.com/ccejournal/fulltext/2024/07000/lung_protective_ventilation_adherence_and_outcomes.23.aspx

Lung Protective Ventilation Adherence and Outcomes for... In period 2, IMCU/ICU LPV adherence was higher versus MICUs, though again not significantly different (RR = 1.09, 95% CI [0.91–1.31]) (p-interaction = 0.06) ( ...

4. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202207-626OC

Delivery of Lung-protective Ventilation for Acute ... Rationale: Lung-protective ventilation (LPV) improves outcomes for patients with acute respiratory distress syndrome (ARDS), but adherence ...

5. chestcc.org chestcc.org/article/S2949-7884(25)00040-1/fulltext

Impact of a Real-Time Ventilator Management Dashboard ... Lung-protective ventilation (LPV), defined as mechanical ventilation with tidal volume (Vt) of ≤ 8 mL/kg ideal body weight (IBW), has been shown ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10884462/

Adherence to lung protective mechanical ventilation in ... This study aimed to determine the adherence rate to the LPV strategy, factors associated with this adherence, and related clinical outcomes

7. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.202207-626OC

Annals of the American Thoracic Society Objectives: To measure the process and clinical impacts of implementation of a science-based intervention to improve LPV adherence for patients ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39018303/

Lung Protective Ventilation Adherence and Outcomes for ... In this study, we compared adherence to lung protective ventilation (LPV) and outcomes for patients with COVID-19-related acute respiratory ...