Brain-injured Patients Extubation Readiness Study

Mechanical Ventilation Clinical Trial

— Biper  

Official title:

Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score

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
• 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
• 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

Related Conditions & MeSH terms

• Acute Brain Injury
• Airway Control
• Altered Level of Consciousness
• Brain Injuries
• Consciousness Disorders
• Mechanical Ventilation
• Mechanical Ventilator Weaning

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)