NCT03468452

Brief Summary

MYASTHENIA GRAVIS (MG) is an autoimmune disease characterized by varying degrees of muscle weakness and fatigability worsened with exertion and relieved with rest。Thymectomy plays an important role in the management of these patients because a consistent association between myasthenic and thymic pathology has been recognized.The need for prolonged mechanical ventilation in these patients after thymectomy is determined by their preoperative condition and various perioperative risk factors. Leventhal et al proposed a preoperative scoring system to predict the need for postoperative mechanical ventilation in myasthenic patients undergoing thymectomy based on the following 4 criteria: duration of MG, chronic respiratory disease, dose of pyridostigmine, and vital capacity. However, some investigators discovered that the Leventhal criteria may not be the sole benchmark and that other criteria such as severity of myasthenia,history of myasthenic crisis, and presence of thymoma may be more important in predicting the necessity for prolonged mechanical ventilation after thymectomy. Naguib et al described multivariate determinants of the need for postoperative ventilation after thymectomy in MG patients predominantly on the basis of pulmonary function tests. In addition, the prevalence and presentation of MG may be variable among different ethnic groups. However, there are very few large studies investigating the determinants of prolonged mechanical ventilation after thymectomy. The authors describe the parameters associated with prolonged mechanical ventilation after trans-sternal thymectomy at their institution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

March 9, 2018

Last Update Submit

March 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of ICU stay

    Record the time spent in hospital for each patient

    through study completion, an average of 1 year

Study Arms (2)

Early extubation

The endotracheal tube is removed in the operation room, and no suction support is required after surgery.

Other: extubation

late extubation

Take the tracheal tube back to the ward for respiratory support or removal of air. The catheter is inserted again within 48h.

Other: extubation

Interventions

Time of extubation

Early extubationlate extubation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

after thymectomy in patients with myasthenia gravis

You may qualify if:

  • myasthenia gravis patients after thymectomy

You may not qualify if:

  • not extubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Airway Extubation

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsInvestigative Techniques

Study Officials

  • Zhenguang Chen

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 16, 2018

Study Start

January 1, 2015

Primary Completion

November 21, 2017

Study Completion

December 11, 2017

Last Updated

March 16, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share