Early Versus Late Extubation in Myasthenia Gravis Patients

Completed

• Conditions: Myasthenia Gravis Associated With Thymoma
• Interventions: Other: extubation

• Registration Number: NCT03468452
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-11-21
• Study Completion: 2017-12-11
• Status Verified: 2018-03
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-03-15
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• myasthenia gravis patients after thymectomy

Exclusion Criteria

• not extubation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early extubation	extubation	The endotracheal tube is removed in the operation room, and no suction support is required after surgery.
late extubation	extubation	Take the tracheal tube back to the ward for respiratory support or removal of air. The catheter is inserted again within 48h.

Primary Outcome Measures

Name	Time	Method
Length of ICU stay	through study completion, an average of 1 year	Record the time spent in hospital for each patient