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Predictors of Weaning Outcomes for Brain Injured Patients

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ClinicalTrials.gov Identifier: NCT02863237
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

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.

Condition or disease
Brain Injuries

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.


Study Type : Observational
Estimated Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Weaning Outcomes for Brain Injured Patients: a Prospective, Observational Cohort Study
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Group/Cohort
weaning failure group
Patients reconnected to the ventilator within 48 hours after SBT will be designated the weaning failure group
weaning success group
Patients who pass the SBT and breathing without ventilator support within 48 hours are designated the weaning success group



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Brain injured patients receiving mechanical ventilation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863237


Contacts
Contact: Jian-Xin Zhou, MD zhoujx.cn@icloud.com

Locations
China, Beijing
ICU, Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Jian-Xin Zhou, MD       zhoujx.cn@icloud.com   
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Jian-Xin Zhou, MD Beijing Tiantan Hospital,Capital Medical University

Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02863237     History of Changes
Other Study ID Numbers: KY2016-018-02
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jian-Xin Zhou, Capital Medical University:
brain injury
mechanical ventilation
weaning

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries