Authorised Therapeutic use (Phase IV) Weaning of Mechanical ventilation

Non-Invasive Ventilation versus High Flow Oxygenotherapy in Patients at High Risk of Extubation Failure

EU CTIS ID: 2024-514640-81-00

What this study is testing

The primary objective will be the reduction of extubation failure.

  • Therapeutic use (Phase IV)

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

Who can take part

You may be able to join if

  • Age ≥ 65 years
  • Hypercapnia (paCO2 > 45 mmHg) at the time of extubation
  • Ineffective cough
  • Abundant secretions
  • Body mass index (BMI)>30
  • Chronic obstructive pulmonary disease (COPD) or asthma as a cause of invasive mechanical ventilation

You likely can't join if

  • Structural neurologic disease
  • Direct extubation without performing a spontaneous breathing trial
  • Contraindication to apply NIV or high flow oxygen
  • Not intubation order
  • Life support therapy limitation
  • Tracheotomized
See the full eligibility criteria
Who can join
  • Age ≥ 65 years
  • Hypercapnia (paCO2 > 45 mmHg) at the time of extubation
  • Ineffective cough
  • Abundant secretions
  • Body mass index (BMI)>30
  • Chronic obstructive pulmonary disease (COPD) or asthma as a cause of invasive mechanical ventilation
  • Cardiac failure as a cause of intubation or history of ejection fraction <= 30%
  • Acute Physiology and Chronic Health Evaluation (APACHE II) > 12 at the time of extubation
  • Time of mechanical ventilation > 7 days
  • Positive water balance
  • Difficult or prolonged weaning
  • Pneumonia (or any medical pathology over surgical) as a cause of ARF
What rules you out
  • Structural neurologic disease
  • Direct extubation without performing a spontaneous breathing trial
  • Contraindication to apply NIV or high flow oxygen
  • Not intubation order
  • Life support therapy limitation
  • Tracheotomized
  • Spinal cord injury
  • Scheduled surgical intervention in the next 48 hours post-extubation
  • Re-admission
  • Transfer to another center
  • Refusal of the patient or relatives

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

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