To compare automated closed-loop ventilation (INTELLiVENT-ASV) to conventional, non-automated ventilation in patients in 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
The primary endpoint is the number of ventilator-free days and alive at day 28
after ICU admission. The co-primary endpoint is the quality of breathing,
defined as time spent within predefined zones of optimal ventilation.
Secondary outcome
Secondary study parameters include:
- ICU length of stay
- Hospital length of stay
- 28-day mortality
- 90-day mortality
- Incidence of ICU mortality
- Incidence of hospital mortality
- Incidence of: development of Acute Respiratory Distress Syndrome (ARDS),
pneumonia, severe atelectasis, pneumothorax, respiratory muscle weakness,
severe hypoxemia and severe hypercapnia
- Incidence of use of rescue therapies for severe hypoxemia or severe
atelectasis (e.g. recruitment maneuver, prone positioning, bronchoscopy for
opening atelectasis)
- Quality of life at day 28
Background summary
INTELLiVENT-adaptive support ventilation (ASV) is an automated closed-loop
ventilation mode, in which ventilator settings are continuously and
automatically adjusted in accordance to a set of broadly accepted guidelines
for invasive ventilation and in response to feedback which the machine
uninterruptedly receives regarding the situation of the patient. While the
safety and feasibility of INTELLiVENT-ASV has been confirmed in several
studies, robust evidence for clinical benefit in comparison to conventional
ventilation is currently missing. The here proposed investigator-initiated
international multicenter randomized clinical trial will provide high-level
evidence for clinical benefit of INTELLiVENT-ASV in a general population of
invasively ventilated intensive care unit (ICU) patients.
Study objective
To compare automated closed-loop ventilation (INTELLiVENT-ASV) to conventional,
non-automated ventilation in patients in the ICU.
Study design
International, multicenter, superiority, randomized controlled trial in
intubated and ventilated adult ICU patients.
Intervention
Patients randomized to the automated closed-loop ventilation-arm are ventilated
with INTELLiVENT-ASV mode; patients randomized to the conventional
ventilation-arm are ventilated with a non-automated mode of ventilation.
Study burden and risks
Differences in burden and risk of the two ventilation strategies are not
expected. Both methods of ventilation are currently used as standard care on
the intensive care unit. No other study interventions are performed. Collection
of demographic data, ventilation data and outcome data causes no harm for the
patients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Admission to an ICU participating in this trial
- Need for invasive ventilation
- An expected duration of ventilation > 24 hours
Exclusion criteria
- Age less than 18 years
- Invasive ventilation longer than 1 hour in the intensive care unit before
randomization
- Invasive ventilation longer than 6 hours directly preceding intensive care
unit admission
- Patients who have recently undergone a pneumectomy or lobectomy
- Patients with suspected or confirmed pregnancy
- Patients with morbid obesity (body mass index > 40)
- Patients with premorbid restrictive pulmonary disease (evidence of chronic
interstitial infiltration on chest radiographs)
- Patients in whom pulse oximetry is known to be unreliable (e.g., patients
with carbon monoxide
poisoning)
- Patients with any neurologic diagnosis that can prolong duration of
mechanical ventilation (e.g., patients with Guillain-Barré syndrome, high
spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or
myasthenia gravis)
- Patients receiving veno-venous, veno-arterial or arterio-venous
extracorporeal membrane
oxygenation (ECMO)
- Previous randomization in this randomized controlled trial
- Patients participating in another study with the same endpoint or
interventions possibly
comprising this study outcome
- No informed consent
Design
Recruitment
Medical products/devices used
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 | NL72786.018.20 |