Clinical trial NCT02863237: Predictors of Weaning Outcomes for Brain Injured Patients
Official title: Predictors of Weaning Outcomes for Brain Injured Patients: a Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Keywords: brain injury
mechanical ventilation
weaning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain injured patients receiving mechanical ventilation

Brief summary: Brian injured patients are predisposed to various complications related to mechanical ventilation. Appropriate decision making of the weaning is crucial and validated predictive parameters are desirable. In present study, the investigators aim to a) validate the electrical activity of diaphragm (EAdi) derived parameters, and b) evaluate the traditional predictive parameters in weaning prediction in brain injured patients.

Detailed description: In general intensive care unit (ICU), about 20% patients are ventilated because of neurological illness. This proportion might be much higher in brain injured patients. As with general intensive care patients, brain injured patients are predisposed to a number of complications associated with mechanical ventilation. Both unnecessarily delaying and premature attempts of withdrawal of mechanical ventilation will increase the rate of complications, prolonged mechanical ventilation, the length of stay, motility, and the cost.

Numerous studies had examined factors that predict combined liberation/extubation outcomes, including vital capacity (VC), minute ventilation(VE), and maximum inspiratory pressure (MIP), airway pressure developed 100 ms after the beginning of inspiration against an occluded airway (P0.1), breathing pattern variability (BPV), and the "rapid shallow breathing index" (RSBI, Breathing frequency-tidal volume ratio, f/Vt). The introduction of Neurally Adjusted Ventilatory Assist (NAVA) has made available a standardized and validated method to monitor and measure diaphragm electrical activity (EAdi) both during conventional modes of ventilation and spontaneous breathing trail (SBT). Neuroventilatory efficiency index (NVE, Tidal volume - EAdi ratio, Vt/EAdi) and neuromechanical efficiency index (NME, tidal volume - EAdi ratio, Paw/EAdi) had also been proposed and showed a promising prospect.

However, all those physiological and mechanical parameters are either have limitations on using in brain injured patients, or have not yet been proved to be validity or even had a poor predictive ability. In part this is because respiratory failure of brain injured patient results from two principle etiologic entities: primary pulmonary dysfunction and neurogenic pulmonary dysfunction. The latter brings us quite different characters of brain injury patients, which required specially consideration. Another reason is that, patients with brain injured but no other indication for mechanical ventilation constitute a group in whom the needs for ventilatory support and for an artificial airway might be separate. Previous study that, in neurosurgical patients passed SBT, a median of 2 days elapsed before the attempted extubation, and 45% patients suffered reintubation or tracheostomies. Nonetheless, in most studies, disconnection of ventilatory support and extubation are often lumped together. Although some studies investigated the factors that are predictive of successful extubation, few study considered about the solely liberation of mechanical ventilation.

Therefore, in present study, the investigators separate the liberation of ventilatory support as a standalone part from the traditional weaning/extubation process. Patients are divided into two groups: weaning success and weaning failure, without consideration of the artificial airway status. The primary aims of the study are: a) validate the EAdi derived values, and b) evaluate the traditional predictive parameters in weaning prediction in brain injured patients.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 80 years
* Mechanical ventilation \> 24 hours
* Fulfilling the weaning screen criteria

Exclusion Criteria:

* Moribund or brain dead
* With spinal injury
* Status epilepsy
* Contraindication to EAdi catheter placement
* Severe cardiac disease
* Company with chest or abdominal injury

Primary outcomes:
measure: Change in Electrical activity of diaphragm measured at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Esophageal pressure
timeFrame: 30 minutes
measure: Change in Respiratory Rate
timeFrame: 30 minutes
measure: Change in Airway pressure
timeFrame: 30 minutes
measure: Change in Intrinsic positive end-expiratory pressure
timeFrame: 30 minutes
measure: Change in Esophageal pressure time product
timeFrame: 30 minutes
measure: Change in Rapid shallow breathing index
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
citation: Shi ZH, Jonkman AH, Tuinman PR, Chen GQ, Xu M, Yang YL, Heunks LMA, Zhou JX. Role of a successful spontaneous breathing trial in ventilator liberation in brain-injured patients. Ann Transl Med. 2021 Apr;9(7):548. doi: 10.21037/atm-20-6407.