To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the amount of MP with each form of invasive
ventilation.
Secondary outcome
N.a.
Background summary
Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung
protective ventilation, consisting of a low tidal volume (VT), a low plateau
pressure (Pplateau) and a low driving pressure (ΔP) improves survival and
shortens duration of ventilation in patients with acute respiratory distress
syndrome (ARDS), and may also benefit critically ill patients with respiratory
failure not caused by ARDS. *Mechanical Power of ventilation* (MP), the amount
of energy per time transferred from the ventilator to the respiratory system,
is a summary variable that includes all the components that play a role in
VILI. With fully-automated closed-loop ventilation, all these components are no
longer set by the operator, but under control of the algorithms in the
ventilator.
Study objective
To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-
automated closed-loop ventilation, with MP under conventional ventilation.
Study design
International, multicenter, crossover, randomized clinical trial.
Intervention
The ventilator will be randomly switched between INTELLiVENT-ASV for 3 hours
and conventional ventilation for 3 hours.
Study burden and risks
Differences in burden and risks of the two ventilation strategies compared in
this study are not expected. Both modes of ventilation are currently
interchangeably used as part of standard care in the participating centers. No
other interventions are performed. Collection of demographic data, ventilation
data and outcome data, causes no harm to the patient.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Admitted to one of the participating ICUs;
• Receiving invasive ventilation through a standard endotracheal tube;
• Expected to be ventilated > 24 hours;
• Ventilation with a ventilator that provides INTELLiVENT-ASV.
Exclusion criteria
• Age under 18 years of age;
• No written informed consent;
• Morbidly obese;
• Any contra-indications for use of INTELLiVENT-ASV
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 |
|---|---|
| CCMO | NL74931.018.20 |