Mechanical Ventilation ComplicationNCT03172169
Specific Small RNA in Plasma for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients
An observational study of Mechanical Ventilation Complication, run by Southeast University, China.
Trial summary
Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group, difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds of MyomiRX and diaphragmatic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2017to 1 Dec 2017
- How long will I take part?
- 3 Months
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for >48 hours and first SBT failure)
Who may be able to join
- healthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for >48 hours and first SBT failure)
Who cannot join
- severe respiratory depression, high paraplegia and neuromuscular lesions;
- esophageal obstruction, esophageal perforation, severe esophageal varices bleeding, upper gastrointestinal surgery and other reasons can not be placed EAdi catheter;
- thoracic deformity and diaphragmatic hernia;
- serious heart, liver, kidney and other organ failure, hemodynamic instability;
- pregnancy;
- the end of the tumor or the family member give up the active treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Observational Study of Specific Small RNA in Plasma Muscle Tissue for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients
Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group, difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds of MyomiRX and diaphragmatic dysfunction. The research value of this project is to explore the predictive value of plasma MyomiRX level on diaphragmatic dysfunction in patients with mechanical ventilation, and to lay the foundation for finding the target of VIDD diagnosis and treatment
Read the detailed description
- research content (1) screening MyomiR through literature review (2) selection of mechanical ventilation group, difficult withdrawal units and three healthy adult groups, method for the detection of plasma MyomiRX level and clinical assessment of diaphragmatic function, observation of the relationship between MyomiRX level and diaphragmatic dysfunction, prediction of plasma MyomiRX levels in patients with mechanical ventilation for diaphragmatic dysfunction in value.
- research objectives Objective to investigate the predictive value of specific minute RNA in plasma muscle tissue on diaphragmatic dysfunction in mechanical ventilation patients Experimental grouping (1) the control group of mechanical ventilation (time of examination, preoperative, admission to ICU and before extubation); (2) difficulty in withdrawal of units (first days, third days and seventh days after the failure of the test time for the first withdrawal); (3) the healthy control group (after the test time was selected)
- Conditions
- Mechanical Ventilation Complication
- Being tested
- no Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no InterventionOther
no Intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | no intervention Receives: Other: no Intervention | |
| Difficult withdrawal group | The mechanical ventilation time was >48 hours and the first SBT failure Receives: Other: no Intervention | |
| Mechanical ventilation control group | Elective and expected postoperative control of mechanical ventilation time greater than 12h after cardiothoracic surgery Receives: Other: no Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of diaphragmatic dysfunction using RT-PCR microRNA level
Prediction of diaphragmatic dysfunction in patients with mechanical ventilation by specific minute RNA of plasma muscle tissue
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- 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
- 140 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- pan chun, doctor, Principal investigator, Colleague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172169
- Sponsor's protocol ID
- miRNA and Diaphragm
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Specific Small RNA in Plasma Muscle Tissue for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03172169
- Acronym / sponsor ID
- miRNA and Diaphragm
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 1 Jun 2017 (actual)
- 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.
Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group, difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds of MyomiRX and diaphragmatic dysfunction. The research value of this project is to explore the predictive value of plasma MyomiRX level on diaphragmatic dysfunction in patients with mechanical ventilation, and to lay the foundation for finding the target of VIDD diagnosis and treatment
Detailed description
- research content (1) screening MyomiR through literature review (2) selection of mechanical ventilation group, difficult withdrawal units and three healthy adult groups, method for the detection of plasma MyomiRX level and clinical assessment of diaphragmatic function, observation of the relationship between MyomiRX level and diaphragmatic dysfunction, prediction of plasma MyomiRX levels in patients with mechanical ventilation for diaphragmatic dysfunction in value.
- research objectives Objective to investigate the predictive value of specific minute RNA in plasma muscle tissue on diaphragmatic dysfunction in mechanical ventilation patients Experimental grouping (1) the control group of mechanical ventilation (time of examination, preoperative, admission to ICU and before extubation); (2) difficulty in withdrawal of units (first days, third days and seventh days after the failure of the test time for the first withdrawal); (3) the healthy control group (after the test time was selected)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | Other: no Interventionno intervention |
| Difficult withdrawal group | – | Other: no InterventionThe mechanical ventilation time was >48 hours and the first SBT failure |
| Mechanical ventilation control group | – | Other: no InterventionElective and expected postoperative control of mechanical ventilation time greater than 12h after cardiothoracic surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for >48 hours and first SBT failure)
Key inclusion criteria (1 listed)
- healthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for >48 hours and first SBT failure)
Key exclusion criteria (6 listed)
- severe respiratory depression, high paraplegia and neuromuscular lesions;
- esophageal obstruction, esophageal perforation, severe esophageal varices bleeding, upper gastrointestinal surgery and other reasons can not be placed EAdi catheter;
- thoracic deformity and diaphragmatic hernia;
- serious heart, liver, kidney and other organ failure, hemodynamic instability;
- pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no Interventionno Intervention | Other | Difficult withdrawal group, Healthy control group, Mechanical ventilation control group |
Primary outcome
Prediction of diaphragmatic dysfunction using RT-PCR microRNA level
Time frame: 7 days
Prediction of diaphragmatic dysfunction in patients with mechanical ventilation by specific minute RNA of plasma muscle tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- 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.
pan chun, doctor principal investigator
Colleague
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, run by Southeast University, 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 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 2017. 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?
Contact xu xiaoting, master (+86 13645188041, xuxiaoting2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of diaphragmatic dysfunction using RT-PCR microRNA level (time frame: 7 days). 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 6 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.