NCT03172169

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

May 29, 2017

Last Update Submit

June 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Healthy control group

no intervention

Other: no Intervention

Difficult withdrawal group

The mechanical ventilation time was \>48 hours and the first SBT failure

Other: no Intervention

Mechanical ventilation control group

Elective and expected postoperative control of mechanical ventilation time greater than 12h after cardiothoracic surgery

Other: no Intervention

Interventions

no Intervention

Difficult withdrawal groupHealthy control groupMechanical ventilation control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • pan chun, doctor

    Colleague

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xu xiaoting, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

June 15, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06