Acute Respiratory Distress Syndrome (ARDS)PRECIPICENCT07519941
Promoting Change in Practice for Respiratory Failure
A study testing Safer sedation bundle in people with Acute Respiratory Distress Syndrome (ARDS), run by New York University.
Trial summary
Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Safer sedation bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We will include physicians, nurses, and other staff at participating ICUs who consent to participate.
Who cannot join
- We will exclude potential participants who cannot speak either English or Spanish.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study
Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. The team's preliminary work identified two potential mechanisms: Hispanic patients with respiratory failure are more likely to be deeply sedated and less likely to receive physical therapy than non-Hispanic patients, which are both associated with mortality and poor long-term functional outcomes. The overall objective of this proposal is to improve outcomes for patients with respiratory failure through changes in intensive care unit (ICU) practice. This trial will refine and pilot an intervention to promote guideline-concordant care. The team's preliminary intervention will be iteratively refined through patient, family, and clinician engagement and piloted at two U.S. ICUs. The outcome of this study will be an intervention aimed at reducing mortality from respiratory failure.
- Being tested
- Safer sedation bundle
- 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.
Safer sedation bundleOther
This is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain.
| Study group | Role | What they receive |
|---|---|---|
| Safer sedation bundle | Experimental | This is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain. Receives: Other: Safer sedation bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability
The co-primary endpoints are acceptability and feasibility. We will measure acceptability and feasibility in surveys using construct definitions from the Consolidated Framework for Implementation Research (CFIR) .
Measured: From enrollment to 3 months
Secondary outcomes (1)
Patient safety culture score
Measured using AHRQ's Survey on Patient Safety Culture.
Measured: Enrollment through 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mari Armstrong-Hough, PhD, MPH, Principal investigator, New York University School of Global Public HealthThomas Valley, MD, MSc, Principal investigator, University of Colorado Anschutz School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519941
- Sponsor's protocol ID
- 1R01HL157361
- Other IDs
- 1R01HL157361
- Acronym
- PRECIPICE
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Small sample size may increase risk of identification if IPD are shared. We will defer to the IRB determination.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study
- ClinicalTrials.gov ID
- NCT07519941
- Acronym / sponsor ID
- PRECIPICE / 1R01HL157361
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Apr 2026 (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.
Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. The team's preliminary work identified two potential mechanisms: Hispanic patients with respiratory failure are more likely to be deeply sedated and less likely to receive physical therapy than non-Hispanic patients, which are both associated with mortality and poor long-term functional outcomes. The overall objective of this proposal is to improve outcomes for patients with respiratory failure through changes in intensive care unit (ICU) practice. This trial will refine and pilot an intervention to promote guideline-concordant care. The team's preliminary intervention will be iteratively refined through patient, family, and clinician engagement and piloted at two U.S. ICUs. The outcome of this study will be an intervention aimed at reducing mortality from respiratory failure.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safer sedation bundle | Experimental | Other: Safer sedation bundleThis is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include physicians, nurses, and other staff at participating ICUs who consent to participate.
Key exclusion criteria (1 listed)
- We will exclude potential participants who cannot speak either English or Spanish.
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 |
|---|---|---|
| Safer sedation bundleThis is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain. | Other | Safer sedation bundle |
Primary outcome
Feasibility and acceptability
Time frame: From enrollment to 3 months
The co-primary endpoints are acceptability and feasibility. We will measure acceptability and feasibility in surveys using construct definitions from the Consolidated Framework for Implementation Research (CFIR) .
1 secondary outcome
Patient safety culture score
Time frame: Enrollment through 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided. Small sample size may increase risk of identification if IPD are shared. We will defer to the IRB determination.
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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.
Mari Armstrong-Hough, PhD, MPH principal investigator
New York University School of Global Public Health
Thomas Valley, MD, MSc principal investigator
University of Colorado Anschutz School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Safer sedation bundle in people with Acute Respiratory Distress Syndrome (ARDS), run by New York University.
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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsea Chobany, MPH (212-992-3723, chelsea.chobany@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability (time frame: From enrollment to 3 months). 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 11 May 2026.