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NCT Number: NCT02863237

Predictors of Weaning Outcomes for Brain Injured Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Electrical activity of diaphragm measured at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

Secondary outcomes

  1. Change in Esophageal pressure

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

  2. Change in Respiratory Rate

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

  3. Change in Airway pressure

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

  4. Change in Intrinsic positive end-expiratory pressure

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

  5. Change in Esophageal pressure time product

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

  6. Change in Rapid shallow breathing index

    Time frame: 30 minutes

    Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Predictors of Weaning Outcomes for Brain Injured Patients: a Prospective, Observational Cohort Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2016
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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