Trial Outcomes & Findings for ED Lung Protective Ventilation to Reduce Complications (NCT NCT02543554)
NCT ID: NCT02543554
Last Updated: 2018-12-03
Results Overview
Recruitment status
COMPLETED
Target enrollment
1705 participants
Primary outcome timeframe
7 days
Results posted on
2018-12-03
Participant Flow
Participant milestones
| Measure |
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
lung protective ventilation: Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.
|
|---|---|---|
|
Overall Study
STARTED
|
1192
|
513
|
|
Overall Study
COMPLETED
|
1192
|
513
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ED Lung Protective Ventilation to Reduce Complications
Baseline characteristics by cohort
| Measure |
Pre-intervention Group
n=1192 Participants
mechanically ventilated patients before implementation of ED lung protective ventilation
|
Intervention Group
n=513 Participants
mechanically ventilated patients after implementation of ED lung protective ventilation
lung protective ventilation: Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.
|
Total
n=1705 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
754 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
1111 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
438 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
594 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 21.1 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 24.0 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
564 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
774 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
628 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
931 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1192 participants
n=5 Participants
|
513 participants
n=7 Participants
|
1705 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Pre-intervention Group
n=1192 Participants
Before implementation of ED lung protection
|
Intervention Group
n=513 Participants
after implementation of ED lung protective ventilation
|
|---|---|---|
|
Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department
|
171 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Patients will be followed for the duration of hospital stayOutcome measures
| Measure |
Pre-intervention Group
n=1192 Participants
Before implementation of ED lung protection
|
Intervention Group
n=513 Participants
after implementation of ED lung protective ventilation
|
|---|---|---|
|
Number of Patients That Die During the Hospitalization
|
338 participants
|
105 participants
|
Adverse Events
Pre-intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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