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

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

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 month

Population: 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

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 month

Development of ARDS after admission to the hospital

Outcome measures

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

Brian M Fuller

Washington University in St. Louis

Phone: 3147475368

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place