Specific Small RNA in Plasma for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients

June 4, 2017 updated by: Chun Pan, Southeast University, China

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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)

Description

Inclusion Criteria:

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)

Exclusion Criteria:

  1. severe respiratory depression, high paraplegia and neuromuscular lesions;
  2. esophageal obstruction, esophageal perforation, severe esophageal varices bleeding, upper gastrointestinal surgery and other reasons can not be placed EAdi catheter;
  3. thoracic deformity and diaphragmatic hernia;
  4. serious heart, liver, kidney and other organ failure, hemodynamic instability;
  5. pregnancy;
  6. the end of the tumor or the family member give up the active treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy control group
no intervention
Other: no Intervention
no Intervention
Difficult withdrawal group
The mechanical ventilation time was >48 hours and the first SBT failure
Other: no Intervention
no Intervention
Mechanical ventilation control group
Elective and expected postoperative control of mechanical ventilation time greater than 12h after cardiothoracic surgery
Other: no Intervention
no Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southeast University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: pan chun, doctor, colleague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • miRNA and Diaphragm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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