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

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

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 ventilation

Mortality at discharge from intensive care unit

Outcome measures

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

Andres Esteban

VENTILA group

Phone: 34916834982

Results disclosure agreements

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