Brain-injured Patients Extubation Readiness Study (Biper)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Airway Control; Acute Brain Injury; Mechanical Ventilator Weaning; Mechanical Ventilation; Altered Level of Consciousness

Treatments: Procedure: Usual Care; Procedure: Extubation readiness clinical score

Study type: Interventional

Funder types: Other

Identifiers

NCT04080440

2018-A00894-51 (Other Identifier)

Biper - PhrcIR 2017 Chabanne

Details and patient eligibility

About

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.

Full 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, 1 point if not

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 command with no or minimal 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.

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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, anoxo ischemic encephalopathy after cardiac arrest or brain tumour
• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Clinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol

Treatment:

Procedure: Usual Care

Extubation readiness clinical score

Experimental group

Description:

Clinicians decide whether to extubate or not following the extubation readiness clinical score as part of their ICU ventilator weaning protocol

Treatment:

Procedure: Extubation readiness clinical score