Systemic Inflammatory Response SyndromeNCT02820090
The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism
An observational study of Systemic Inflammatory Response Syndrome and Ventilator Weaning, run by Beijing Chao Yang Hospital.
Trial summary
Infection and trauma take a important role in the acute respiratory failure.There are different causes and degrees of inflammatory reaction in the critically ill patient. The inflammatory reaction should also affect patients on mechanical ventilation dependence with body physiological response and disease prognosis in… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Ventilator Weaning
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Apr 2017
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patient with oral or nasal tracheal intubation and mechanical ventilation in respiratory failure
Who may be able to join
- oral, nasal tracheal intubation and mechanical ventilation in patients with respiratory failure
- mechanical ventilation time over than 48 hours
- Glasgow score greater more than or equal to 13 points
Who cannot join
- Aged less than 14 years or more than 80 years old
- patients with neuromuscular disease
- pure heart failure pulmonary edema patients
- patients with tracheotomy
About this study
Infection and trauma take a important role in the acute respiratory failure.There are different causes and degrees of inflammatory reaction in the critically ill patient. The inflammatory reaction should also affect patients on mechanical ventilation dependence with body physiological response and disease prognosis in patients. Therefore, the investigators hypothesize that inflammation may have an important role in the prediction of weaning from mechanical ventilation.
Read the detailed description
In the process of mechanical ventilation, the patients were divided into two groups according to the failure of spontaneous breathing test and spontaneous breathing test.In the index of predicting mechanical ventilation, the investigators will take the index of inflammatory response, the function index of diaphragm and the amount of exhaled CO2 into account to reduce the failure rate of mechanical ventilation.
- Keywords
- Inflammatory Factor, Mechanical Ventilation
- Medical subject headings
- Systemic Inflammatory Response Syndrome
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 |
|---|---|---|
| Success with SBT | The patient have a success in SBT. | |
| Success with mechanical ventilation | Weaning from mechanical ventilation is successful | |
| failure with SBT | The patient have a failure in SBT. | |
| failure with mechanical ventilation | Weaning from mechanical ventilation is failed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between mechanical ventilation of ventilator and inflammatory response
Through the study of mechanical ventilation weaning success and failure of patients with respiratory physiological indicators, blood, urine related inflammatory indicators, analysis of the relationship between inflammatory response and mechanical ventilation weaning.The test indicators include C- reactive protein, tumor necrosis factor and some interleukin for related.
Measured: January 2014 to December 2016
Secondary outcomes (2)
The relationship between diaphragm movement function and weaning from mechanical ventilation
To study the relationship between the inflammatory response and the contractile function of diaphragm, which is helpful to judge the effect of inflammatory factors on the evacuation of mechanical ventilation.
Measured: January 2016 to December 2017
the output of CO2
Measured: January 2016 to December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingmin Ma, Beijing Chao Yang Hospital
- Investigators
- MA yingmin, professor, Study director, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820090
- Sponsor's protocol ID
- 15210511726
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism
- ClinicalTrials.gov ID
- NCT02820090
- Acronym / sponsor ID
- 15210511726
- Keywords
- Inflammatory Factor, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Jun 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.
Infection and trauma take a important role in the acute respiratory failure.There are different causes and degrees of inflammatory reaction in the critically ill patient. The inflammatory reaction should also affect patients on mechanical ventilation dependence with body physiological response and disease prognosis in patients. Therefore, the investigators hypothesize that inflammation may have an important role in the prediction of weaning from mechanical ventilation.
Detailed description
In the process of mechanical ventilation, the patients were divided into two groups according to the failure of spontaneous breathing test and spontaneous breathing test.In the index of predicting mechanical ventilation, the investigators will take the index of inflammatory response, the function index of diaphragm and the amount of exhaled CO2 into account to reduce the failure rate of mechanical ventilation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Success with SBT | – | –The patient have a success in SBT. |
| Success with mechanical ventilation | – | –Weaning from mechanical ventilation is successful |
| failure with SBT | – | –The patient have a failure in SBT. |
| failure with mechanical ventilation | – | –Weaning from mechanical ventilation is failed |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient with oral or nasal tracheal intubation and mechanical ventilation in respiratory failure
Key inclusion criteria (3 listed)
- oral, nasal tracheal intubation and mechanical ventilation in patients with respiratory failure
- mechanical ventilation time over than 48 hours
- Glasgow score greater more than or equal to 13 points
Key exclusion criteria (4 listed)
- Aged less than 14 years or more than 80 years old
- patients with neuromuscular disease
- pure heart failure pulmonary edema patients
- patients with tracheotomy
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
The relationship between mechanical ventilation of ventilator and inflammatory response
Time frame: January 2014 to December 2016
Through the study of mechanical ventilation weaning success and failure of patients with respiratory physiological indicators, blood, urine related inflammatory indicators, analysis of the relationship between inflammatory response and mechanical ventilation weaning.The test indicators include C- reactive protein, tumor necrosis factor and some interleukin for related.
2 secondary outcomes
The relationship between diaphragm movement function and weaning from mechanical ventilation
Time frame: January 2016 to December 2017
the output of CO2
Time frame: January 2016 to December 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Individual participant dataSharing planned: Yes
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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.
MA yingmin, professor study director
Beijing Chao Yang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome and Ventilator Weaning, run by Beijing Chao Yang Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The relationship between mechanical ventilation of ventilator and inflammatory response (time frame: January 2014 to December 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2016.