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Brain InjuriesNCT02863237

Predictors of Weaning Outcomes for Brain Injured Patients

An observational study of Brain Injuries, run by Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Brain Injuries
How many people
46 participants
Where
1 siteChina
Study dates
Jun 2016to Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Brain injured patients receiving mechanical ventilation

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • ICU, Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Brain Injuries
Keywords
brain injury, mechanical ventilation, weaning
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02863237
Study groupRoleWhat they receive
weaning failure groupPatients reconnected to the ventilator within 48 hours after SBT will be designated the weaning failure group
weaning success groupPatients who pass the SBT and breathing without ventilator support within 48 hours are designated the weaning success group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 30 minutes

Secondary outcomes (6)
  1. Change in Esophageal pressure

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

    Measured: 30 minutes

  2. Change in Respiratory Rate

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

    Measured: 30 minutes

  3. Change in Airway pressure

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

    Measured: 30 minutes

  4. Change in Intrinsic positive end-expiratory pressure

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

    Measured: 30 minutes

  5. Change in Esophageal pressure time product

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

    Measured: 30 minutes

  6. Change in Rapid shallow breathing index

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

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2018
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02863237
Sponsor's protocol ID
KY2016-018-02
Status last verified
Jan 2018
First submitted
1 Aug 2016
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33987246

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injuries, run by Capital Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02863237, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

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