BridgeMD
New treatment option for Mechanical Ventilator Weaning
Official title Brain-injured Patients Extubation Readiness Study
ClinicalTrials.gov ID: NCT04080440
What this study is testing
- What it's testing
- The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.
- 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 to 75
You may be able to join if
- Acute cerebral lesion with a Glasgow Coma Scale \<13 needing admission in ICU and mechanical ventilation with tracheal intubation for neurological...
- Mechanical ventilation more than 48 hours
- 18 to 75 years old
- Neurological stability with no intracranial hypertension with minimal sedation
- Glasgow Coma Scale motor response \< 6
You likely can't join if
- Posterior cranial fossa lesion
- Admission for status epilepticus or central nervous system infection
- Spinal cord injury (tetraplegia or paraplegia)
- Uncontrolled status epilepticus or uncontrolled central nervous system infection
- Care limitation plan
- Chronic respiratory failure defined as ambulatory oxygen therapy or pressure support ventilation and/or proven COPD and/or ambulatory non-invasive...
See the full eligibility criteria
- Acute cerebral lesion with a Glasgow Coma Scale \<13 needing admission in ICU and mechanical ventilation with tracheal intubation for neurological cause : cerebrovascular stroke either ischemic or hemorrhagic including...
- Mechanical ventilation more than 48 hours
- 18 to 75 years old
- Neurological stability with no intracranial hypertension with minimal sedation
- Glasgow Coma Scale motor response \< 6
- Spontaneous breathing trial succeeded
- First extubation attempt
- Posterior cranial fossa lesion
- Admission for status epilepticus or central nervous system infection
- Spinal cord injury (tetraplegia or paraplegia)
- Uncontrolled status epilepticus or uncontrolled central nervous system infection
- Care limitation plan
- Chronic respiratory failure defined as ambulatory oxygen therapy or pressure support ventilation and/or proven COPD and/or ambulatory non-invasive CPAP therapy for sleep apnoea syndrome
- More than 3 failed spontaneous breathing trials
- Significant chest trauma (more than 2 broken ribs / broken sternum / with an indication of open thoracic surgery)
- Surgery planned within 7 days
- Tracheotomy or previous extubation outside of the protocol
- Previous compromised upper airway permeability
- Pregnant or breastfeeding woman
- Adult under the protection of the law or without social assurance system
- Inclusion in another clinical study about mechanical ventilation or weaning
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Bourg-en-Bresse, France
- Caen, France
- Clermont-Ferrand, France
- Grenoble, France
- La Réunion, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Nîmes, France
- Paris, France
- Poitiers, France
- Rennes, France
- Saint-Etienne, France
- Toulouse, France
- Valence, France
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Bourg-en-Bresse, France; Caen, France; Clermont-Ferrand, France; Grenoble, France and 14 more location(s). 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.