Comparing different ventilation strategies in focal and non-focal ARDS in invasively ventilated patients admitted to the intensive care unit.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mortality at day 90 (day of ARDS diagnosis considered as day 0).
Secondary outcome
Secondary outcomes are mortality at 30 days, ventilator free days (VFD) at day
28, ICU length of stay, ICU mortality, hospital length of stay, hospital
mortality, complications as a result of ventilation.
Background summary
Acute respiratory distress syndrome (ARDS) is a severe lung disease with a 30%
mortality rate that affects one in four ventilated patients in the intensive
care unit. Personalized ventilation based on lung morphology in this patient
population has the potential to reduce mortality. The LIVE study recently
showed that application of personalized ventilation in practice is limited by a
high interobserver variability in the determination of the type of lung
morphology. This variability is caused by poor assessment of chest X-rays and
the complex assessment and low availability of computed tomography (CT) scans.
Correct determination of lung morphology is essential because incorrect
ventilation strategies leads to a significant increase in mortality. Recently,
our research group has developed a lung ultrasound method that can accurately
determine lung morphology on the basis of a decision tree compared to CT scans.
With the help of this study it will become clear whether personalized
ventilation based on lung morphology, using lung ultrasound, will lead to a
decrease in mortality in invasively ventilated patients with ARDS.
Study objective
Comparing different ventilation strategies in focal and non-focal ARDS in
invasively ventilated patients admitted to the intensive care unit.
Study design
A multicenter randomized controlled trial.
Intervention
Within 24 hours of inclusion, patients undergo a long ultrasound to distinguish
between focal and non-focal ARDS. After differentiation, patients are
randomized into the personalized ventilation group or the control group.
Ventilation strategies per group will be as follows:
Personalized ventilation focal ARDS:
- Tidal volume: 6-8 ml/kg PBW
- PEEP: <10 cmH2O
- Mandatory prone position
Personalized Ventilation Non-focal ARDS:
- Tidal volume: 4-6 ml/kg PBW
- PEEP: >15 cmH2O
- Mandatory recruitment manoeuvres.
Control group ventilation strategy:
- Tidal volume: 6 ml/kg PBW
- PEEP: According to the PEEP/FiO2 table of the ALVEOLI study, with a maximum
peak pressure below 30 cmH2O
- Prone position is encouraged
Except for different ventilation strategies, other aspects of treatment will be
the same for all groups.
Study burden and risks
We do not expect a difference in risk and burden between the different
ventilation strategies and the use of lung ultrasound, as these techniques are
already used in standard care of invasively ventilated patients with ARDS.
Collecting demographics, ventilation parameters and outcome measures does not
harm the patient
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Admitted to a participating ICU, invasively ventilated, fulfil the Berlin
criteria for moderate or severe ARDS.
Exclusion criteria
Age under 18, pregnant, participation in an other interventional studie,
conditions in which lung ultrasound is not feasible (e.g. subcutaneous
emphysema, morbid obesity or wounds), mechanical ventilation for longer than 7
consecutive days in the past 30 days, history of ARDS in the previous month,
body-mass index higher than 40 kg/m², intracranial hypertension,
broncho-pleural fistula, chronic respiratory diseases requiring long-term
oxygen therapy or respiratory support, pulmonary fibrosis, patients who are
moribund or facing end of life and no informed consent.
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79110.018.21 |