PRotective VENTilation in Patients Without ARDS at Start of Ventilation - PReVENT, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 952
- Locations
- 1
- Primary Endpoint
- Ventilator-free days
Study Overview
Brief Summary
The purpose of this national multicentre randomized controlled trial is to compare a ventilation strategy using lower tidal volumes and higher respiratory rates with a ventilation strategy using higher tidal volumes and a lower respiratory rate in intubated and ventilated intensive care unit (ICU) patients without Acute Respiratory Distress Syndrome (ARDS) at start of ventilation.
Participating centres in The Netherlands will include a total of 952 adult patients admitted to intensive care units without ARDS. Patients are randomized and ventilated with either a strategy with lower tidal volumes (4 to 6 ml/kg predicted body weight (PBW)) or a strategy with higher tidal volumes (8 to 10 ml/kg PBW). Patients will be assessed every day until day 28 or discharge of the intensive care unit, whichever comes first, on day 28 and on day 90. Primary endpoint is the number of ventilator-free days at day 28. Secondary endpoints are ICU- and hospital length of stay (LOS) and - mortality, the incidence of development of ARDS, pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives, and neuromuscular blocking agents, incidences of ICU delirium and ICU acquired weakness, patient-ventilator asynchrony and the need for decreasing of instrumental dead space.
Detailed Description
Research question:
Does mechanical ventilation with lower tidal volumes, as compared with mechanical ventilation with higher tidal volumes, increase the number of ventilator-free days at day 28 in patients without ARDS at start of ventilation?
Study Design:
An investigator-initiated, national, multicenter, parallel randomized controlled two-arm trial.
Centers:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 a clinical diagnosis of ARDS according to the Berlin definition
- •Patients with a PaO2/FiO2 < 200 mm Hg in whom hypoxia is presumably not caused by cardiac failure or fluid overload
- •Invasive ventilation longer than 12 hours directly preceding 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
Arms & Interventions
Ventilation with lower tidal volumes
Use of low tidal volume (4 to 6 ml/kg PBW) after intubation and during all mechanical ventilation
Intervention: low tidal volume (Procedure)
Ventilation with higher tidal volumes
Use of high tidal volume (8 to 10 ml/kg PBW) after intubation and during all mechanical ventilation
Intervention: high tidal volume (Procedure)
Outcomes
Primary Outcomes
Ventilator-free days
Time Frame: first 28 days after start of ventilation
The number of ventilator-free days, defined as the number of days from day 1 to day 28 on which a patient breathes without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours.
Secondary Outcomes
- Intensive care unit length of stay(first 90 days after start of ventilation)
- Cumulative use and duration of sedatives and neuromuscular blocking agents(first 28 days after start of ventilation or discharge from intensive care)
- ICU delirium(first 28 days after start of ventilation or discharge from intensive care)
- Pulmonary complications(first 28 days after start of ventilation or discharge from intensive care)
- Hospital length of stay(first 90 days after start of ventilation)
- ICU- Acquired Weakness(first 28 days after start of ventilation or discharge from intensive care)
- Mortality(first 90 days after start of ventilation)
Investigators
Prof. Dr. Marcus J. Schultz
Principal Investigator and Clinical Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)