The objective of this crossover study and randomized controlled trial is to compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective ventilation in patients with moderate or severe ARDS.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Transpulmonary driving pressure
Secondary outcome
- End expiratory pressure in the respiratory system
- End expiratory pressure in the esophagus
- End inspiratory pressure in the respiratory system
- End inspiratory pressure in the esophagus
- tidal volume (Vt)
- positive end-expiratory pressure (PEEP)
- plateau pressure (Pplat)
- peak pressure (Ppeak)
- respiratory rate (RR)
- fraction of inspired oxygen (FiO2)
- exhaled CO2 (etCO2 en VCO2)
- peripheral oxygen saturation (spO2)
- CO2 tension in arterial blood (PaCO2)
- oxygen tension in arterial blood (PaO2)
- oxygen saturation in arterial blood (saO2)
- pH of arterial blood
- bicarbonate in arterial blood (HCO3)
Background summary
Mechanical ventilation is a mandatory intervention in patients with acute
respiratory distress syndrome (ARDS). Mechanical ventilation can cause or
worsen lung injury. Additional lung injury is partly prevented by using low
driving pressures (<15cm H2O). There are strong indications that an automated
ventilation modality, INTELLiVENT-ASV, leads to a lower driving pressure than
in conventional lung protective ventilation. Esophageal pressure measurement
can help differentiate between pleural and alveolar pressure; only alveolar
pressure is associated with lung injury.
Study objective
The objective of this crossover study and randomized controlled trial is to
compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective
ventilation in patients with moderate or severe ARDS.
Study design
International multi-center crossover study and randomized controlled trial.
Intervention
One group will be ventilated with INTELLiVENT-ASV, the other group will be
ventilated with conventional lung protective ventilation. Extra esophageal
pressure measurements will be performed.
Study burden and risks
INTELLiVENT®-ASV has been found to be a safe and efficient ventilatory mode in
patients with ARDS, and to be at least as safe as conventional lung protective
ventilation. The burden and risks of ventilation with INTELLiVENT®-ASV are
comparable to that of conventional lung protective ventilation. The extra
esophageal pressure measurements will not cause extra burden and risks for the
subjects. The intervention can lead to a reduction in transpulmonary driving
pressure, this can benefit the patient.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Moderate/severe ARDS
- Intubated and ventilated
- Within 24 hours of initial diagnosis of ARDS
Exclusion criteria
- Age <18
- Previously included in this study or other interventional trial that could influence ventilation parameters
- Suspected or confirmed pregnany
- Increased or uncontrollable intracranial pressure
- Contra-indication for esophageal pressure measurement
Design
Recruitment
Medical products/devices used
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 | NCT03211494 |
| CCMO | NL56754.018.16 |