Early Versus Late Extubation in Myasthenia Gravis Patients

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03468452
Collaborator
(none)
96
35.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: extubation

Detailed Description

Perioperative variables collected from the patient records were demographic data, duration of the disease,severity of the disease based on Osserman's classification, antiacetylcholine receptor (AChR) antibody positivity, preoperative drug therapy, history of preoperative myasthenic crisis, technique of anesthesia, drugs used for anesthesia, perioperative complications, and duration of postoperative mechanical ventilation. Even though the MG classification by the Myasthenia Gravis Foundation of America is widely accepted,disease severity was graded according to the Osserman and Genkins classification preoperatively as per the authors' institutional protocol.

Study Design

Study Type:
Observational
Actual Enrollment :
96 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Early Versus Late Extubation After Thymectomy in Patients With Myasthenia Gravis: A Retrospective Analysis
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Nov 21, 2017
Actual Study Completion Date :
Dec 11, 2017

Arms and Interventions

Arm Intervention/Treatment
Early extubation

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

Other: extubation
Time of 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
Time of extubation

Outcome Measures

Primary Outcome Measures

  1. Length of ICU stay [through study completion, an average of 1 year]

    Record the time spent in hospital for each patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • myasthenia gravis patients after thymectomy
Exclusion Criteria:
  • not extubation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Zhenguang Chen, First Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GengLong Liu, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT03468452
Other Study ID Numbers:
  • Timing of Extubation
First Posted:
Mar 16, 2018
Last Update Posted:
Mar 16, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2018