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.
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
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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.
- First posted11 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Study chair, Beijing Tiantan Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Weaning Outcomes for Brain Injured Patients: a Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02863237
- Acronym / sponsor ID
- KY2016-018-02
- Conditions
- Brain Injuries
- Keywords
- brain injury, mechanical ventilation, weaning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Brain injured patients receiving mechanical ventilation
Key inclusion criteria (3 listed)
- Age between 18 to 80 years
- Mechanical ventilation > 24 hours
- Fulfilling the weaning screen criteria
Key exclusion criteria (6 listed)
- Moribund or brain dead
- With spinal injury
- Status epilepsy
- Contraindication to EAdi catheter placement
- Severe cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Change in Esophageal pressure
Time frame: 30 minutes
Change in Respiratory Rate
Time frame: 30 minutes
Change in Airway pressure
Time frame: 30 minutes
Change in Intrinsic positive end-expiratory pressure
Time frame: 30 minutes
Change in Esophageal pressure time product
Time frame: 30 minutes
Change in Rapid shallow breathing index
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 33987246Shi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Xin Zhou, MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
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.