Recruiting NA Mechanical Ventilation

New treatment option for Mechanical Ventilation

Official title Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill Invasively Ventilated Patients

ClinicalTrials.gov ID: NCT07077174

What this study is testing

What it's testing
RATIONALE Lung-protective ventilation using a lower respiratory rate (RR) is an appealing strategy to reduce ventilation intensity, which may require permissive hypercapnia. However, the feasibility and safety of this so-called 'permissive lung-protective ventilation' must be investigated, before conducting a large randomized clinical trial to evaluate its effectiveness on patient-centered outcomes.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • admission to one of the participating ICUs;
  • intubated and receiving invasive ventilation with an expected duration of ventilation of at least 24 hours.

You likely can't join if

  • age below 18 years;
  • receiving invasive ventilation \> 1 hour in the ICU, or receiving invasive ventilation \> 6 hours directly preceding the current ICU admission (i.e...
  • receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO);
  • having COPD GOLD III and IV;
  • contra-indication for hypercapnia, such as ongoing cardiac ischemia (as defined in the guideline of the European Society of Cardiology), or having...
  • any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic...
See the full eligibility criteria
Who can join
  • admission to one of the participating ICUs;
  • intubated and receiving invasive ventilation with an expected duration of ventilation of at least 24 hours.
What rules you out
  • age below 18 years;
  • receiving invasive ventilation \> 1 hour in the ICU, or receiving invasive ventilation \> 6 hours directly preceding the current ICU admission (i.e., in the operating room or in the emergency department);
  • receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO);
  • having COPD GOLD III and IV;
  • contra-indication for hypercapnia, such as ongoing cardiac ischemia (as defined in the guideline of the European Society of Cardiology), or having suspected or confirmed increased intracranial pressure due to brain...
  • any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis;
  • suspected or confirmed pregnancy;
  • participation in another treatment trial using similar endpoints;
  • previously assigned by chance in this study;
  • no informed consent; or
  • admitted for terminal care

The study team makes the final eligibility decision.

Where it's taking place

  • Almelo, Netherlands
  • Amsterdam, Netherlands
  • Delft, Netherlands
  • Hoorn, Netherlands
  • Barcelona, Spain

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Almelo, Netherlands; Amsterdam, Netherlands; Delft, Netherlands; Hoorn, Netherlands; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.