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

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: Unknown
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Other: no Intervention

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: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: xu xiaoting, master; Phone Number: +86 13645188041; Email: xuxiaoting2005@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	7 days

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: pan chun, doctor, colleague

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 4, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID 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