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Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study

Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01628523
Enrollment
219
Registered
2012-06-26
Start date
2012-07-31
Completion date
2014-03-31
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Mechanical Ventilation, Respiratory Failure

Keywords

Respiratory failure, Mechanical ventilation, Acute lung injury

Brief 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. 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.

Interventions

OTHERFor 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

Sponsors

University of Iowa
CollaboratorOTHER
Christiana Care Health Services
CollaboratorOTHER
University of Cincinnati
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Ventilation either via an endotracheal tube or tracheostomy

Exclusion criteria

* Non-invasive positive pressure ventilation; * Death in the immediate post-intubation phase of care; * Chronic ventilator-dependence, either at home or extended care facility.

Design outcomes

Primary

MeasureTime frameDescription
To Further Characterize ED Mechanical Ventilation1 monthIn a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.

Secondary

MeasureTime frameDescription
The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS1 monthDevelopment of ARDS after admission to the hospital

Countries

United States

Participant flow

Participants by arm

ArmCount
Entire Cohort
Characteristics of mechanically ventilated ED patients
219
Total219

Baseline characteristics

CharacteristicEntire Cohort
Age, Customized
age
55.6 years
STANDARD_DEVIATION 19.9
Race/Ethnicity, Customized
black
59 participants
Race/Ethnicity, Customized
other
8 participants
Race/Ethnicity, Customized
white
152 participants
Sex: Female, Male
Female
91 Participants
Sex: Female, Male
Male
128 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
72 / 219
other
Total, other adverse events
0 / 219
serious
Total, serious adverse events
0 / 219

Outcome results

Primary

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.

Time frame: 1 month

Population: Tidal volume used for the entire cohort

ArmMeasureValue (MEDIAN)
Entire CohortTo Further Characterize ED Mechanical Ventilation500 mL
Secondary

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

Time frame: 1 month

ArmMeasureValue (NUMBER)
Entire CohortThe Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS30 participants
p-value: <0.05Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026