PRotective VENTilation in Patients not Fulfilling the Consensus Definition for Moderate or Severe ARDS at Start of Ventilation * PReVENT, a Randomized Controlled Trial

Completed

Conditions: Acute Lung Damage
Acute Respiratory Distress Syndrome
10038716

Registration Number: NL-OMON44972

Lead Sponsor: Intensive Care Volwassenen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 952

Inclusion Criteria

- Admission to an ICU participating in this trial
- Need for intubation
- Within 1 hour of admission from the operation room or emergency room (if still intubated and ventilated), or within 1 hour of start of invasive ventilation in the ICU
- An expected duration of ventilation > 24 hours

Exclusion Criteria

* Age less than 18 years
* Patients previously randomized in PReVENT
* Patients participating in other interventional trials
* Patients with moderate or severe ARDS (for Berlin consensus definition see table 1. APPENDIX I)
* Any session of ventilation > 12 hours directly preceding this ICU admission
* Patients with suspected or confirmed pregnancy
* Patients with increased and uncontrollable intracranial pressure (of *18 mmHg)
* Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD)
* Patients with asthmatic status
* Patients with premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on previous chest radiographs)
* Patients with new proven pulmonary thrombo*embolism
* Patients with any previous pneumectomy or lobectomy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of ventilator-free days at day 28 after ICU admission. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> ICU and hospital length of stay (LOS) (follow up till day 90); incidence of<br /><br>moderate or severe ARDS, pneumonia, atelectases, and pneumothorax; cumulative<br /><br>use and duration of sedatives, and neuromuscular blocking agents; incidence of<br /><br>ICU delirium, ICU acquired weakness, ICU mortality and hospital mortality,<br /><br>90-day mortality. </p><br>