REstricted versus Liberal positive end*expiratory pressure in patients without Acute respiratory distress syndrome (RELAx) * a multicenter randomized controlled trial

Completed

• Conditions: 10024967; respiratory insufficiency

• Registration Number: NL-OMON45335
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 980

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of ventilator*free days and alive at day 28<br /><br>after ICU admission. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include:<br /><br>* ICU length of stay (LOS), Hospital LOS<br /><br>* ICU mortality, Hospital mortality, 90-day mortality<br /><br>* Incidence of development ARDS<br /><br>* Incidence of severe hypoxemia<br /><br>* Incidence of severe atelectasis<br /><br>* Rescue therapies for severe hypoxemia: recruitment maneuver, prone position<br /><br>* Rescue therapies for severe atelectasis: bronchoscopy<br /><br>* Incidence of hemodynamic compromise<br /><br>* Incidence of pneumothorax<br /><br>* Incidence of pneumonia<br /><br>* Days with use of hemodynamic support<br /><br>* Days with use of sedation</p><br>