Mechanical Ventilation Clinical Trial
— BiperOfficial title:
Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
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.
Status | Recruiting |
Enrollment | 660 |
Est. completion date | October 13, 2027 |
Est. primary completion date | March 13, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion 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 aneurysmal subarachnoid hemorrhage, traumatic brain injury or anoxo ischemic encephalopathy after cardiac arrest - Mechanical ventilation more than 48 hours - 18 to 75 yers old - Neurological stability with no intracranial hypertension with minimal sedation - Glasgow Coma Scale motor response < 6 - Spontaneous breathing trial succeeded - First extubation attempt - Affiliated to French Social Assurance System Exclusion Criteria: - Posterior Cerebral Fossa lesion - Status epilepticus - Spinal cord injury (tetraplegia or paraplegia) - Central nervous system infection - Life expectancy less than 48 hours or withdrawal of life sustaining therapy - Chronic respiratory failure - More than 3 failed spontaneous breathing trials - Chest trauma - Surgery planned within 7 days - Tracheotomy - Previous compromised upper airway permeability - Pregnant woman - Adult under the protection of the law |
Country | Name | City | State |
---|---|---|---|
France | CHU | Angers | |
France | CHU | Bordeaux | |
France | CHU | Bordeaux | |
France | CH | Bourg-en-Bresse | |
France | CHU | Caen | |
France | CHU | Clermont-Ferrand | |
France | CHU | Grenoble | |
France | CHU | La Réunion | |
France | CHU | Lille | |
France | Hospices Civils de Lyon | Lyon | |
France | APHM | Marseille | |
France | CHU | Montpellier | |
France | CHU | Nantes | |
France | Pasteur 2 Hospital - University Hospital | Nice | |
France | CHU | Nîmes | |
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris | |
France | CHU | Poitiers | |
France | CHU | Rennes | |
France | CHU | Saint-Etienne | |
France | CHU | Toulouse | |
France | CH | Valence |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | ANARLF Network, AZUREA Network (www.azurea.org), Direction Générale de l'Offre de Soin (DGOS) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extubation failure | Extubation failure is defined as a need of reintubation or death | Day 5 (Day 0 = Extubation) | |
Secondary | Invasive mechanical ventilation duration | Period expressed in days during which patients will need invasive mechanical ventilation | End of the ICU Stay or Day 90 (Day 0 = Extubation) | |
Secondary | Non-invasive mechanical ventilation duration | Period expressed in days during which patients will need non-invasive mechanical ventilation | End of the ICU Stay or Day 90 (Day 0 = Extubation) | |
Secondary | Reintubation rate | Patients needing reintubation during entire ICU stay | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | Reintubation rate | Patients needing reintubation during entire ICU stay | Until Day 2 (Day 0 = Extubation) | |
Secondary | Causes of reintubation | Causes of reintubation if needed | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | ICU length of stay | ICU length of stay expressed in days | End of ICU Stay or Day 90 (Day 0 = Extubation) | |
Secondary | Post extubation nosocomial pneumonia | Post extubation nosocomial pneumonia is defined as a pulmonary infection after extubation that necessitate antibiotic therapy | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | Tracheotomy before extubation | Number of patients that necessitate a tracheotomy after a successful spontaneous breathing trial but before extubation | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | Tracheotomy after extubation | Number of patients that necessitate a tracheotomy afetr extubation failure | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | Neurological outcome | Neurological outcome using the Glasgow Outcome Scale Extended | Day 90 (Day 0 = Extubation) | |
Secondary | Hospital length of stay | Hospital length of stay expressed in days | End of Hospital Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | Mortality | Deceased patient in each group | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | |
Secondary | Mortality | Deceased patient in each group | Day 28 (Day 0 = Extubation) | |
Secondary | Mortality | Deceased patient in each group | Day 90 (Day 0 = Extubation) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05921656 -
Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
|
||
Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
Withdrawn |
NCT04288076 -
The Brain and Lung Interaction (BALI) Study
|
N/A | |
Completed |
NCT03031860 -
Semi-quantitative Cough Strength Score (SCSS)
|
N/A | |
Completed |
NCT02312869 -
Local Assessment of Management of Burn Patients
|
N/A | |
Completed |
NCT02545621 -
A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
|
||
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT01204281 -
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
|
Phase 4 | |
Terminated |
NCT01059929 -
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
|
Phase 4 | |
Completed |
NCT00824239 -
Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients
|
Phase 3 | |
Completed |
NCT00529347 -
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern
|
Phase 1 | |
Unknown status |
NCT00260676 -
Protective Ventilatory Strategy in Potential Organ Donors
|
Phase 3 | |
Terminated |
NCT00205517 -
Sedation and Psychopharmacology in Critical Care
|
N/A | |
Completed |
NCT03281785 -
Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.
|
N/A | |
Recruiting |
NCT04110613 -
RCT: Early Feeding After PEG Placement
|
N/A | |
Completed |
NCT04410783 -
The Emergency Department Sedation Pilot Trial
|
N/A | |
Recruiting |
NCT04821453 -
NAVA vs. CMV Crossover in Severe BPD
|
N/A | |
Completed |
NCT03930147 -
Ventilation With ASV Mode in Children
|
N/A | |
Recruiting |
NCT05029167 -
REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study)
|
N/A | |
Recruiting |
NCT04849039 -
Lung Microbiota and VAP Development (PULMIVAP)
|