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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04080440
Other study ID # Biper - PhrcIR 2017 Chabanne
Secondary ID 2018-A00894-51
Status Recruiting
Phase N/A
First received
Last updated
Start date February 9, 2020
Est. completion date October 13, 2027

Study information

Verified date September 2023
Source University Hospital, Clermont-Ferrand
Contact Laclautre
Phone +33 4 73 754963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Severe brain-injured patients need mechanical ventilation with tracheal intubation. After treatment of the acute neurological condition, weaning of the mechanical ventilation has to be initiated notably to prevent ventilator associated pneumonia and others complications. Nevertheless, extubation failure is very common in this population due to residual neurological impairment with airway control alteration. Guidelines about weaning of mechanical ventilation and extubation exclude brain-injured patients with a residual impaired consciousness. In 2017, a simple and pragmatic extubation readiness clinical score was validated in a prospective observational cohort study of 140 brain injured patients. (Godet et al. Anesthesiology. 2017 Jan;126(1):104-114) In this study, brain injured patients with residual impaired consciousness who succeeded a spontaneous breathing trial were extubated. In multivariate analysis, 4 clinical elements were associated with extubation success. A prediction score was determined using the odds ratio such as followed : 1. Deglutition: 3 points if present 2. Gag reflex: 4 points if present 3. Cough: 4 points if present 4. CRS-R Score, visual item > 2, 3 points if present For a cut-off value of 9, extubation failure could be predicted with a sensibility of 84%, a specificity of 75%, a positive predictive value of 89% and a negative predictive value of 66%. In order to participate, brain-injured patients will have to succeed a spontaneous breathing trial and meet all inclusion criteria, including not being able to obey to simple orders without sedation. Using a stepped wedge randomisation process with intensive care units as clusters, patients will be weaned and extubated under usual care or using the extubation readiness clinical score. The authors' hypothesis is that this clinical score will allow physicians to extubate patients at the right time interval and prevent extubation failure in this frail population.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Extubation readiness clinical score
After treatment of the acute neurological condition, elligibility for a spontaneous breathing trial will be assessed 2 times a day. In the intervention group, after a successful spontaneous breathing trial in unconscious patients, the score will be evaluated. If the score is >9, extubation has to be completed
Standard of care
After treatment of the acute neurological condition, elligibility for a spontaneous breathing trial will be assessed 2 times a day. In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to the standard of care

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand ANARLF Network, AZUREA Network (www.azurea.org), Direction Générale de l'Offre de Soin (DGOS)

Country where clinical trial is conducted

France, 

Outcome

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)
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