Acute Respiratory Distress SyndromeNCT03984175
Clinical Decision Support for Mechanical Ventilation of Patients With ARDS
A study testing Implementation of Processes in people with Acute Respiratory Distress Syndrome, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical 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?
- Implementation of Processes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2018to 23 Dec 2022
- 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
- Invasive mechanical ventilation
- PF ratio <255
- Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
- Presence of ≥1 risk factor for ARDS as determined by review of the HER
Who cannot join
- Age <18 years
- Pulmonary capillary wedge pressure >18 mm Hg if a right heart catheter is present
- Prisoner
- Known to be pregnant
- Death <24 hours from initial intubation
- Placed comfort care <24 hours from initial intubation
- Mechanically ventilated for >7 days prior to meeting ARDS criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Valerie Aston, 801-507-4606, valerie.aston@imail.org
Carlos Barbagelata, 801-507-4607, carlos.barbagelata@imail.org
About this study
Official title: Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical ventilation protocols currently available in the investigator's Cerner electronic health record (EHR).
Read the detailed description
A multidisciplinary team of implementation researchers and clinical effectiveness researchers has been assembled to adapt the Consolidated Framework for Implementation Research (CFIR) for this planning study. The team identified the baseline clinical care delivery for LTVV in patients with ARDS across Intermountain hospitals and identified the barriers and facilitators to this standard of care. This pilot implementation study will focus on a Pilot Solution aimed at achieving ideal clinical care delivery of LTVV for patients with ARDS.
Abbreviations for Mechanical Ventilation:
PEEP: positive end expiratory pressure FIO2: fraction of inspired oxygen CPAP: continuous positive airway pressure PS: pressure support VC: volume control VC+: hybrid mode for volume targeted ventilation on Puritan Bennett ventilators PRVC: pressure regulated volume control, hybrid mode for volume targeted ventilation on Draeger ventilators PF ratio: ratio of partial pressure of arterial oxygen (PaO2 mmHg) divided by the FIO2 expressed in liters
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Implementation of Processes
- Keywords
- ARDS, Lung Protective Mechanical Ventilation, Clinical Decision Support
- 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.
Implementation of ProcessesProcedure or surgery
Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol
| Study group | Role | What they receive |
|---|---|---|
| Patients with ARDS at three Intermountain tertiary hospitals | Experimental | Not described Receives: Procedure: Implementation of Processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
LTVV Compliance
Defined as: % of time each patient is on a compliant tidal volume for the duration of mechanical ventilation.
Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for each patient (proportion of mechanically ventilated hours, excluding hours on appropriate CPAP/PS)
Measured: through study completion - 6 months
Secondary outcomes (7)
PEEP FI02 Compliance (continuous variable)
Defined as: % of time each patient is on a compliant FI02 and PEEP combination.
Measured as: using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations, (proportion of ventilated hours, excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS)
Measured: through study completion - 6 months
Utilization of Ventilation Protocol (continuous)
Defined as: % of time each patient is managed with the computerized ventilation protocol.
Measured as: Running the computerized ventilation protocol whenever a ventilator check is performed and an arterial blood gas was done within the previous hour, excluding hours on appropriate CPAP/PS
Measured: through study completion - 6 months
Utilization of Oxygenation Protocol (continuous)
Defined as: % of time each patient is managed with the computerized oxygenation protocol.
Measured as: Running the computerized oxygenation protocol at least every four hours when a ventilator check was performed, excluding hours on appropriate CPAP/PS
Measured: through study completion - 6 months
LTVV Compliance >90% (binary)
Defined as: meeting, or not meeting, the target LTVV compliance of >90% for each patient.
Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for 90% or more of mechanically ventilated hours, excluding hours on appropriate CPAP/PS
Measured: through study completion - 6 months
PEEP FI02 Compliance >70% (binary)
Defined as: meeting, or not meeting, the target PEEP FI02 compliance of >70% for each patient.
Measured as: Using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations for at least 70% of mechanically ventilated hours (excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS)
Measured: through study completion - 6 months
Ventilator-Free Days (VFD) to Day 28
Measured: through study completion - 6 months
% of Patients who do not survive to day 28
Measured: through study completion - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start8 Jul 2018
- Primary completion23 Dec 2022 (estimated)
- Study completion23 Dec 2022 (estimated)
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and After Comparison
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), McKay-Dee Hospital, Utah Valley Hospital, Dixie Regional Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984175
- Sponsor's protocol ID
- 1050867
- Status last verified
- Aug 2022
- First submitted
- 3 Jun 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peltan ID, Knighton AJ, Barney BJ, Wolfe D, Jacobs JR, Klippel C, Allen L, Lanspa MJ, Leither LM, Brown SM, Srivastava R, Grissom CK. Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial. Ann Am Thorac Soc. 2023 Mar;20(3):424-432. doi: 10.1513/AnnalsATS.202207-626OC.
PubMed 36350983
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03984175
- Acronym / sponsor ID
- 1050867
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Lung Protective Mechanical Ventilation, Clinical Decision Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), McKay-Dee Hospital, Utah Valley Hospital, Dixie Regional Hospital
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 23 Dec 2022 (estimated)
- First posted
- 12 Jun 2019 (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.
Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical ventilation protocols currently available in the investigator's Cerner electronic health record (EHR).
Detailed description
A multidisciplinary team of implementation researchers and clinical effectiveness researchers has been assembled to adapt the Consolidated Framework for Implementation Research (CFIR) for this planning study. The team identified the baseline clinical care delivery for LTVV in patients with ARDS across Intermountain hospitals and identified the barriers and facilitators to this standard of care. This pilot implementation study will focus on a Pilot Solution aimed at achieving ideal clinical care delivery of LTVV for patients with ARDS.
Abbreviations for Mechanical Ventilation:
PEEP: positive end expiratory pressure FIO2: fraction of inspired oxygen CPAP: continuous positive airway pressure PS: pressure support VC: volume control VC+: hybrid mode for volume targeted ventilation on Puritan Bennett ventilators PRVC: pressure regulated volume control, hybrid mode for volume targeted ventilation on Draeger ventilators PF ratio: ratio of partial pressure of arterial oxygen (PaO2 mmHg) divided by the FIO2 expressed in liters
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and After Comparison
| Arm | Type | Receives |
|---|---|---|
| Patients with ARDS at three Intermountain tertiary hospitals | Experimental | Procedure: Implementation of Processes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Invasive mechanical ventilation
- PF ratio <255
- Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
- Presence of ≥1 risk factor for ARDS as determined by review of the HER
Key exclusion criteria (7 listed)
- Age <18 years
- Pulmonary capillary wedge pressure >18 mm Hg if a right heart catheter is present
- Prisoner
- Known to be pregnant
- Death <24 hours from initial intubation
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 |
|---|---|---|
| Implementation of ProcessesImplementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol | Procedure or surgery | Patients with ARDS at three Intermountain tertiary hospitals |
Primary outcome
LTVV Compliance
Time frame: through study completion - 6 months
Defined as: % of time each patient is on a compliant tidal volume for the duration of mechanical ventilation. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for each patient (proportion of mechanically ventilated hours, excluding hours on appropriate CPAP/PS)
7 secondary outcomes
PEEP FI02 Compliance (continuous variable)
Time frame: through study completion - 6 months
Utilization of Ventilation Protocol (continuous)
Time frame: through study completion - 6 months
Utilization of Oxygenation Protocol (continuous)
Time frame: through study completion - 6 months
LTVV Compliance >90% (binary)
Time frame: through study completion - 6 months
PEEP FI02 Compliance >70% (binary)
Time frame: through study completion - 6 months
Ventilator-Free Days (VFD) to Day 28
Time frame: through study completion - 6 months
% of Patients who do not survive to day 28
Time frame: through study completion - 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 36350983Peltan ID, Knighton AJ, Barney BJ, Wolfe D, Jacobs JR, Klippel C, Allen L, Lanspa MJ, Leither LM, Brown SM, Srivastava R, Grissom CK. Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial. Ann Am Thorac Soc. 2023 Mar;20(3):424-432. doi: 10.1513/AnnalsATS.202207-626OC.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Processes in people with Acute Respiratory Distress Syndrome, run by Intermountain Health Care, Inc. 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin K Grissom, MD (801-507-6554, colin.grissom@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LTVV Compliance (time frame: through study completion - 6 months). 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 NCT03984175, 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 3 Aug 2022.