Respiratory FailureNCT01628523
Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
An observational study of Respiratory Failure and Mechanical Ventilation, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
Despite its life-saving potential, the mechanical ventilator has great potential to do harm. Despite years of research, the mortality in acute lung injury (ALI) remains very high. Treatment options after ALI onset are very limited, therefore prevention may be the best option. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation, Acute Lung Injury
- What is being tested?
- For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.
- How many people
- 219 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2012to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to the emergency department requiring invasive mechanical ventilation.
Who may be able to join
- Ventilation either via an endotracheal tube or tracheostomy
Who cannot join
- Non-invasive positive pressure ventilation;
- Death in the immediate post-intubation phase of care;
- Chronic ventilator-dependence, either at home or extended care facility.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Cincinnati College of Medicine
Cincinnati, Ohio
University of Iowa College of Medicine
Iowa City, Iowa, 52242
Christiana Care Health System
Newark, Delaware, 19718
Washington University School of Medicine
St Louis, Missouri
About this study
Despite its life-saving potential, the mechanical ventilator has great potential to do harm. Despite years of research, the mortality in acute lung injury (ALI) remains very high. Treatment options after ALI onset are very limited, therefore prevention may be the best option. Unfortunately, the emergency department has not been studied with respect to mechanical ventilation practices, and its contribution to ALI is unknown. The investigators hypothesize that mechanical ventilation is frequently used in the ED and for a variety of reasons, and that ED mechanical ventilation has an effect on long term outcomes.
- Being tested
- For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.
- Keywords
- Respiratory failure, Mechanical ventilation, Acute lung injury
- Medical subject headings
- Respiratory Insufficiency, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.Other
Mechanical ventilation via an endotracheal tube or tracheostomy tube
| Study group | Role | What they receive |
|---|---|---|
| All ED patients requiring mechanical ventilation | Not described Receives: Other: For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Further Characterize ED Mechanical Ventilation
In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.
Measured: 1 month
Secondary outcomes (1)
The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS
Development of ARDS after admission to the hospital
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionMar 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Christiana Care Health Services, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Brian M Fuller, MD, Principal investigator, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628523
- Sponsor's protocol ID
- 201205165
- Status last verified
- Mar 2020
- First submitted
- 20 Jun 2012
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fuller BM, Mohr NM, Miller CN, Deitchman AR, Levine BJ, Castagno N, Hassebroek EC, Dhedhi A, Scott-Wittenborn N, Grace E, Lehew C, Kollef MH. Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study. Chest. 2015 Aug;148(2):365-374. doi: 10.1378/chest.14-2476.
PubMed 25742126
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT01628523
- Acronym / sponsor ID
- 201205165
- Keywords
- Respiratory failure, Mechanical ventilation, Acute lung injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Iowa, Christiana Care Health Services, University of Cincinnati
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite its life-saving potential, the mechanical ventilator has great potential to do harm. Despite years of research, the mortality in acute lung injury (ALI) remains very high. Treatment options after ALI onset are very limited, therefore prevention may be the best option. Unfortunately, the emergency department has not been studied with respect to mechanical ventilation practices, and its contribution to ALI is unknown. The investigators hypothesize that mechanical ventilation is frequently used in the ED and for a variety of reasons, and that ED mechanical ventilation has an effect on long term outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All ED patients requiring mechanical ventilation | – | Other: For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to the emergency department requiring invasive mechanical ventilation.
Key inclusion criteria (1 listed)
- Ventilation either via an endotracheal tube or tracheostomy
Key exclusion criteria (3 listed)
- Non-invasive positive pressure ventilation;
- Death in the immediate post-intubation phase of care;
- Chronic ventilator-dependence, either at home or extended care facility.
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 |
|---|---|---|
| For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.Mechanical ventilation via an endotracheal tube or tracheostomy tube | Other | All ED patients requiring mechanical ventilation |
Primary outcome
To Further Characterize ED Mechanical Ventilation
Time frame: 1 month
In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.
1 secondary outcome
The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25742126Fuller BM, Mohr NM, Miller CN, Deitchman AR, Levine BJ, Castagno N, Hassebroek EC, Dhedhi A, Scott-Wittenborn N, Grace E, Lehew C, Kollef MH. Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study. Chest. 2015 Aug;148(2):365-374. doi: 10.1378/chest.14-2476.
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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.
Brian M Fuller, MD principal investigator
Washington University School of Medicine in St. Louis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Mechanical Ventilation, run by Washington University School of Medicine at 4 sites 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 3 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 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 23 Mar 2020). 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?
To Further Characterize ED Mechanical Ventilation (time frame: 1 month). 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 NCT01628523, 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 23 Mar 2020.