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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44972

Enrollment

952

Registered

2014-05-15

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Damage Acute Respiratory Distress Syndrome

Interventions

Patients are randomly assigned in a 1:1 ratio to lower tidal volume ventilation (4-6 ml/kg predicted body weight) or ventilation with higher tidal volumes (8-10 ml/kg predicted body weight)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The number of ventilator-free days at day 28 after ICU admission.	—

Secondary

Measure	Time frame
ICU and hospital length of stay (LOS) (follow up till day 90); incidence of moderate or severe ARDS, pneumonia, atelectases, and pneumothorax; cumulative use and duration of sedatives, and neuromuscular blocking agents; incidence of ICU delirium, ICU acquired weakness, ICU mortality and hospital mortality, 90-day mortality.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)