Trial Outcomes & Findings for Third International Study on Mechanical Ventilation (NCT NCT01093482)
NCT ID: NCT01093482
Last Updated: 2018-03-01
Results Overview
Mortality at discharge from intensive care unit
Recruitment status
COMPLETED
Target enrollment
8151 participants
Primary outcome timeframe
At day 28 after the beginning of mechanical ventilation
Results posted on
2018-03-01
Participant Flow
Consecutive patients who required mechanical ventilation for more than 12 hours in the participating intensive care units.
Participant milestones
| Measure |
Mechanically Ventilated Patients
1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
|
|---|---|
|
Overall Study
STARTED
|
8151
|
|
Overall Study
COMPLETED
|
8151
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Third International Study on Mechanical Ventilation
Baseline characteristics by cohort
| Measure |
Mechanically Ventilated Patients
n=8151 Participants
1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4233 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3918 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5046 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 28 after the beginning of mechanical ventilationMortality at discharge from intensive care unit
Outcome measures
| Measure |
Mechanically Ventilated Patients
n=8151 Participants
1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
|
|---|---|
|
All-cause Mortality
|
2269 Participants
|
Adverse Events
Mechanically Ventilated Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2269 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