Lower tidal volumes in order to reduce VILI and days on the ventilator which will reduce the number of days on the ICU
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end-point:
- Number of ventilator-free days during the 28 days immediatly after
randomization.
Secondary outcome
Secondary end-point:
- 28-day all-cause mortality
- 90-day all-cause mortality
- Number of ICU-free days during the 28 days immediatly after randomization
- Cumulative incidence of first episode of refractory hypoxemia (first 28 days)
- Cumulative incidence of the use of rescue therapies
- Cumulative incidence of first day that meet criteria for weaning readiness
during 28 days after randomization
- Cumulative SOFA-free score between randomization and day 28
- Cumulatieve incidence of severe adverse events during 28 days after
randomization
Background summary
Acute Respiratory Distress Syndrome (ARDS) is characterized by acute onset of
bilateral infiltrates on chest X-ray, pulmonary artery wedge pressure <18mmHg
or absence of clinical evidence of high left atrial pressure, and a PaO2/FiO2
ratio =<200.
ARDS patienten do need mechanical ventilation, but this also causes damage to
the lungs, this is called Ventilator induced Lung Injury (VILI). Since the
ARDSnet trial (2000) it is known that ARDS patienten have a higher survival
using low tidal volumes (6mL/kg), because this causes less damage.
By using even lower tidal volumes (4mL/kg) VILI will be reduced. Although the
problem with such a small tidal volumes is the fact that carbon dioxide levels
will increase in the blood. By using a DECAP machine the blood will be filtered
extra-corporeal, using the dialyse concept.
Veneous blood will be transported to the DECAP device using a coaxial (two-way)
catheter. The DECAP will wash-out the CO2 and pumps the blood through the
catheter back to the patient. Using mechanical ventilation the blood will be
oxygenated.
Study objective
Lower tidal volumes in order to reduce VILI and days on the ventilator which
will reduce the number of days on the ICU
Study design
Patients will be randomized into two groups after informed consent.
Control group:
- Ventilation following the ARDSnet protocol
- Tidal volumes of 6mL/kg predicted body weight
- Oxygenation of 55-80 mmHg of SpO2 88-95%
- Plateau pressure <30 cm H2O
- Arterial pH 7.30-7.45
Intervention group:
- Tidal volumes of 4mL/kg predicted body weight
- Oxygenation 55-80 mmHg of SpO2 88-95%
- Plateau pressure =<25 cm H2O
- arterial pH 7.30-7.45
- ECCO2-R to remove CO2 from the blood
Intervention
Mechanical ventilation with lower tidal volumes (4mL/kg).
Connection to DECAP using a coaxiale (two-way) catheter, which will transport
blood to and from the patient.
Study burden and risks
DECAP is based on the dialyse concept.
To avoid coagulation inside the system, the patient will receive heparine.
Heparine will slow-down the coagulation which will increase the risk of
bleedings.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- age > 18 years
- are on invasive assisted breathing less then 48 hours
- Less than 24 hours since diagnosis for ARDS: with PF<=200 and PEEP>=10, bilateral infiltrates on chest X-Ray and no clinical evidence of left artrial hypertension
- have a commitment to full support
Exclusion criteria
- Intubation and mechanical ventilation for > 48 hours
- risk of systemic bleeding with anticoagulation
- acute brain injury
- body mass index >40
- Pregnancy
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01522599 |
| CCMO | NL39966.078.12 |