Acute Respiratory Distress SyndromeIMPROVENTNCT03225807
Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
An observational study of Acute Respiratory Distress Syndrome and ARDS, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, ARDS, Respiratory Distress Syndrome, Acute
- How many people
- 8,692 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 Dec 2022
- Phase
- Observational
- 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
Study population: Patient Selection Those to be enrolled must have respiratory failure requiring intubation and initiation of mechanical ventilation. Patients will be divided into two different groups: those patients who are managed with the computerized lung protective ventilation protocol as ordered by the attending physician and those patients managed with physician specified mechanical ventilation settings.
Who may be able to join
- Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
- Age ≥ 18 years
Who cannot join
- Transition to comfort care in the emergency department or on the same day of admission to the ICU
- Death on the same day of admission to the emergency department or ICU
Trial locations and contacts
1 site in 1 country.
About this study
This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes.
The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes.
Read more
The objectives of this study are to:
- Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation
- Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS)
- Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals
Read the detailed description
Study Design:
This is an observational quality improvement study comparing outcomes before, and after, implementation of a proven lung protective ventilation protocol in an electronic medical record system, iCentra, that will be implemented in phases across Intermountain Healthcare hospitals. A phased implementation with a two-month washout period will be used to evaluate the primary outcome of interest, ventilator free days (VFDs) to 28 days. Secondary outcomes will include: use of the protocol by clinicians, compliance with protocol instructions, hospital discharge disposition, hospital, 30-day, and 90-day mortality, time to first ICU activity, hospital length of stay, ICU length of stay, heath care utilization, quality of life, and costs of care. As the iCentra electronic medical record is implemented at Intermountain Healthcare hospitals, clinicians will have the opportunity to use the computerized lung protective ventilation protocol, or to order mechanical ventilation settings independently. This is an observational study designed to measure how often the computerized lung protective ventilation protocol will be ordered, compliance with the instructions of the protocol, and clinical outcomes among patients who are managed with the protocol. Physicians may choose to use the protocol on intubated patients requiring mechanical ventilation or they may choose to order other specific mechanical ventilator settings.
- Conditions
- Acute Respiratory Distress Syndrome, ARDS, Respiratory Distress Syndrome, Acute, Respiratory Insufficiency, Respiratory Distress Syndrome, Shock Lung
- Keywords
- Intubated, Intubation, Ventilator, Ventilator-free days, Ventilator free days, Mechanical Ventilation, Meta-Analysis, Tidal Volume, Tidal Volumes, inflammation, cytokines, Pulmonary Infiltrate, Pulmonary Infiltrates, Low Tidal Volumes, Protective Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Severe Acute Respiratory Syndrome, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days to day 28
Measured: 28 days
Secondary outcomes (5)
30 day mortality
Measured: 30 days
90 day mortality
Measured: 90 days
Hospital discharge disposition
Measured: 30 days
Hospital mortality
Measured: 1 week
Time to first ICU activity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startMar 2016
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Grissom, Intermountain Health Care, Inc.
- Investigators
- Colin Grissom, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225807
- Sponsor's protocol ID
- 1050159
- Acronym
- IMPROVENT
- Status last verified
- Mar 2024
- First submitted
- 14 Jul 2017
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data will not be shared.
Publications
Grissom CK, Lanspa MJ, Groat D, Jacobs JR, Carpenter L, Kuttler KG, Leither L, Peltan ID, Brown SM, Srivastava R. Implementation of Lung-Protective Ventilation in Patients With Acute Respiratory Failure. Crit Care Med. 2023 Jun 1;51(6):797-807. doi: 10.1097/CCM.0000000000005840. Epub 2023 Mar 29.
PubMed 36988337
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT03225807
- Acronym / sponsor ID
- IMPROVENT / 1050159
- Conditions
- Acute Respiratory Distress Syndrome, ARDS, Respiratory Distress Syndrome, Acute, Respiratory Insufficiency, Respiratory Distress Syndrome, Shock Lung
- Keywords
- Intubated, Intubation, Ventilator, Ventilator-free days, Ventilator free days, Mechanical Ventilation, Meta-Analysis, Tidal Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,692 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Jul 2017 (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.
This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes.
The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes.
The objectives of this study are to:
- Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation
- Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS)
- Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals
Detailed description
Study Design:
This is an observational quality improvement study comparing outcomes before, and after, implementation of a proven lung protective ventilation protocol in an electronic medical record system, iCentra, that will be implemented in phases across Intermountain Healthcare hospitals. A phased implementation with a two-month washout period will be used to evaluate the primary outcome of interest, ventilator free days (VFDs) to 28 days. Secondary outcomes will include: use of the protocol by clinicians, compliance with protocol instructions, hospital discharge disposition, hospital, 30-day, and 90-day mortality, time to first ICU activity, hospital length of stay, ICU length of stay, heath care utilization, quality of life, and costs of care. As the iCentra electronic medical record is implemented at Intermountain Healthcare hospitals, clinicians will have the opportunity to use the computerized lung protective ventilation protocol, or to order mechanical ventilation settings independently. This is an observational study designed to measure how often the computerized lung protective ventilation protocol will be ordered, compliance with the instructions of the protocol, and clinical outcomes among patients who are managed with the protocol. Physicians may choose to use the protocol on intubated patients requiring mechanical ventilation or they may choose to order other specific mechanical ventilator settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient Selection Those to be enrolled must have respiratory failure requiring intubation and initiation of mechanical ventilation. Patients will be divided into two different groups: those patients who are managed with the computerized lung protective ventilation protocol as ordered by the attending physician and those patients managed with physician specified mechanical ventilation settings.
Key inclusion criteria (2 listed)
- Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Transition to comfort care in the emergency department or on the same day of admission to the ICU
- Death on the same day of admission to the emergency department or ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilator free days to day 28
Time frame: 28 days
5 secondary outcomes
30 day mortality
Time frame: 30 days
90 day mortality
Time frame: 90 days
Hospital discharge disposition
Time frame: 30 days
Hospital mortality
Time frame: 1 week
Time to first ICU activity
Time frame: 24 hours
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 12 Mar 2024.
- Derived from this study: PubMed 36988337Grissom CK, Lanspa MJ, Groat D, Jacobs JR, Carpenter L, Kuttler KG, Leither L, Peltan ID, Brown SM, Srivastava R. Implementation of Lung-Protective Ventilation in Patients With Acute Respiratory Failure. Crit Care Med. 2023 Jun 1;51(6):797-807. doi: 10.1097/CCM.0000000000005840. Epub 2023 Mar 29.
- Individual participant dataSharing planned: No. Individual data will not be shared.
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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.
Colin Grissom, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and ARDS, 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 2 inclusion and 2 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 12 Mar 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?
Ventilator free days to day 28 (time frame: 28 days). 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 NCT03225807, 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 12 Mar 2024.