Trial Outcomes & Findings for Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study (NCT NCT01628523)
NCT ID: NCT01628523
Last Updated: 2020-03-23
Results Overview
In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.
Recruitment status
COMPLETED
Target enrollment
219 participants
Primary outcome timeframe
1 month
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
All ED Patients Requiring Mechanical Ventilation
Assessed for mechanical ventilation parameters, predictors of ARDS in the patients without ARDS in the ED (n=204), and outcome differences between all patients with ARDS (n=45) and those not progressing to ARDS (n= 174). These 45 patients includes the 15 patients with ARDS in the ED and the 30 participants with incident ARDS after ED admission.
|
|---|---|
|
Overall Study
STARTED
|
219
|
|
Overall Study
COMPLETED
|
219
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
Baseline characteristics by cohort
| Measure |
Entire Cohort
n=219 Participants
Characteristics of mechanically ventilated ED patients
|
|---|---|
|
Age, Customized
age
|
55.6 years
STANDARD_DEVIATION 19.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
152 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black
|
59 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Tidal volume used for the entire cohort
In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.
Outcome measures
| Measure |
Entire Cohort
n=219 Participants
Characteristics of mechanically ventilated ED patients
|
|---|---|
|
To Further Characterize ED Mechanical Ventilation
|
500 mL
Interval 450.0 to 520.0
|
SECONDARY outcome
Timeframe: 1 monthDevelopment of ARDS after admission to the hospital
Outcome measures
| Measure |
Entire Cohort
n=204 Participants
Characteristics of mechanically ventilated ED patients
|
|---|---|
|
The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS
|
30 participants
|
Adverse Events
All ED Patients Requiring Mechanical Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 72 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place