To compare ventilation with PEEP titrated to the lowest possible PEEP level (restricted) with ventilation the currently practiced PEEP level (liberal) in intensive care patients without 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
The primary endpoint is the number of ventilator*free days and alive at day 28
after ICU admission.
Secondary outcome
Secondary study parameters include:
* ICU length of stay (LOS), Hospital LOS
* ICU mortality, Hospital mortality, 90-day mortality
* Incidence of development ARDS
* Incidence of severe hypoxemia
* Incidence of severe atelectasis
* Rescue therapies for severe hypoxemia: recruitment maneuver, prone position
* Rescue therapies for severe atelectasis: bronchoscopy
* Incidence of hemodynamic compromise
* Incidence of pneumothorax
* Incidence of pneumonia
* Days with use of hemodynamic support
* Days with use of sedation
Background summary
While there is sufficient evidence from randomized controlled trials for
benefit of positive end*expiratory pressure (PEEP) in intensive care unit (ICU)
patients with acute respiratory distress syndrome (ARDS), evidence for benefit
of PEEP in ICU patients without ARDS is absent. PEEP may even be harmful, as it
could cause pulmonary overdistension and cardiac compromise.
Study objective
To compare ventilation with PEEP titrated to the lowest possible PEEP level
(restricted) with ventilation the currently practiced PEEP level (liberal) in
intensive care patients without ARDS.
Study design
National multicenter, non*inferiority, randomized controlled trial in intubated
and ventilated adult intensive care patients without ARDS.
Intervention
Patients randomized to the restricted PEEP-arm are ventilated with the lowest
possible PEEP level (0-5 cm H2O); patients randomized to the liberal PEEP-arm
are ventilated with the currently practiced PEEP level (8 cm H2O). Patients
will be randomly assigned in a 1:1 ratio the restricted PEEP-arm of the liberal
PEEP-arm.
Study burden and risks
Burden and risk of the two ventilation strategies are uncertain. Ventilation
with the lowest possible PEEP level could increase the risk of atelectasis and
also the risk of potentially dangerous hypoxemia, while ventilation with the
currently practiced PEEP level could increase the amount of overdistended lung
tissue and increase hemodynamic compromise. Collection of data causes no harm
for the patients.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
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
* Patient previously randomized in this RCT
* Patient participating in another RCT with the same endpoint or interventions possibly compromising this study outcome
* Patients with ongoing cardiac ischemia due to cardiac infarction and failed revascularization, patients with increased and uncontrollable intracranial pressure (of * 18 mmHg), patients with necrotizing fasciitis, and severe untreatable anemia such as in case of Jehovah*s Witnesses (as these patients can be considered to be vulnerable to the potentially dangerous hypoxemia which could develop more often, even for a short time, in the *restricted PEEP**arm of this trial)
* Patient with a clinical diagnosis of ARDS or possible ARDS with a PaO2/ FiO2 <200 mmHg
* Invasive ventilation longer than 12 hours directly preceding ICU admission
* Invasive ventilation longer than 1 hour before randomization
* Patients with suspected or confirmed pregnancy
* Patients with morbid obesity (body mass index > 40)
* Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD)
* 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
* 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
* No informed consent
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 |
|---|---|
| CCMO | NL60402.018.17 |