Mechanical VentilationNCT02543554
ED Lung Protective Ventilation to Reduce Complications
An observational study of Mechanical Ventilation and Ventilator-associated Conditions, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Ventilator-associated Conditions, ARDS
- What is being tested?
- lung protective ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 1,705 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: mechanically ventilated patients in the emergency department
Who may be able to join
- mechanically ventilated via an endotracheal tube in the ED
Who cannot join
- death in the ED,
- death or discontinuation of ventilation within 24 hours,
- chronic mechanical ventilation,
- ARDS while in the ED
- transfer to another hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washinton University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
Official title: The Effect of Lung Protective Ventilation Initiated in the Emergency Department on the Incidence of Pulmonary Complications and Clinical Outcomes
Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that ED-based mechanical ventilation has significant room for improvement and may also be a causative factor in ARDS incidence.
Read the detailed description
This is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.
- Being tested
- lung protective ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung protective ventilationProcedure or surgery
Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention group | mechanically ventilated patients before implementation of ED lung protective ventilation | |
| Intervention group | mechanically ventilated patients after implementation of ED lung protective ventilation Receives: Procedure: lung protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department
Measured: 7 days
Secondary outcomes (1)
Number of Patients That Die During the Hospitalization
Measured: Patients will be followed for the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Fuller, Washington University School of Medicine
- Investigators
- Brian M Fuller, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543554
- Sponsor's protocol ID
- 201409024
- Status last verified
- May 2018
- First submitted
- 28 Aug 2015
- Last updated
- 3 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberts BW, Mohr NM, Ablordeppey E, Drewry AM, Ferguson IT, Trzeciak S, Kollef MH, Fuller BM. Association Between Partial Pressure of Arterial Carbon Dioxide and Survival to Hospital Discharge Among Patients Diagnosed With Sepsis in the Emergency Department. Crit Care Med. 2018 Mar;46(3):e213-e220. doi: 10.1097/CCM.0000000000002918.
PubMed 29261567Fuller BM, Ferguson I, Mohr NM, Stephens RJ, Briscoe CC, Kolomiets AA, Hotchkiss RS, Kollef MH. Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications. BMJ Open. 2016 Apr 11;6(4):e010991. doi: 10.1136/bmjopen-2015-010991.
PubMed 27067896
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lung Protective Ventilation Initiated in the Emergency Department on the Incidence of Pulmonary Complications and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02543554
- Acronym / sponsor ID
- 201409024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,705 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 3 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that ED-based mechanical ventilation has significant room for improvement and may also be a causative factor in ARDS incidence.
Detailed description
This is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention group | – | –mechanically ventilated patients before implementation of ED lung protective ventilation |
| Intervention group | – | Procedure: lung protective ventilationmechanically ventilated patients after implementation of ED lung protective ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechanically ventilated patients in the emergency department
Key inclusion criteria (1 listed)
- mechanically ventilated via an endotracheal tube in the ED
Key exclusion criteria (5 listed)
- death in the ED,
- death or discontinuation of ventilation within 24 hours,
- chronic mechanical ventilation,
- ARDS while in the ED
- transfer to another hospital.
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 |
|---|---|---|
| lung protective ventilationLung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia. | Procedure or surgery | Intervention group |
Primary outcome
Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department
Time frame: 7 days
1 secondary outcome
Number of Patients That Die During the Hospitalization
Time frame: Patients will be followed for the duration of hospital stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29261567Roberts BW, Mohr NM, Ablordeppey E, Drewry AM, Ferguson IT, Trzeciak S, Kollef MH, Fuller BM. Association Between Partial Pressure of Arterial Carbon Dioxide and Survival to Hospital Discharge Among Patients Diagnosed With Sepsis in the Emergency Department. Crit Care Med. 2018 Mar;46(3):e213-e220. doi: 10.1097/CCM.0000000000002918.
- Derived from this study: PubMed 27067896Fuller BM, Ferguson I, Mohr NM, Stephens RJ, Briscoe CC, Kolomiets AA, Hotchkiss RS, Kollef MH. Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications. BMJ Open. 2016 Apr 11;6(4):e010991. doi: 10.1136/bmjopen-2015-010991.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
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Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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.
Brian M Fuller, MD, MSCI principal investigator
Washington University School of Medicine
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 Mechanical Ventilation and Ventilator-associated Conditions, run by Washington University School of Medicine 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 5 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 3 Dec 2018. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department (time frame: 7 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 NCT02543554, which also lists 2 linked publications.
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 Dec 2018.