Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:

Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03597373
• Other study ID #: Reintubation
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: July 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Genglong Liu
• Phone: +8615626405844
• Email: lglong3[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Myasthenia gravis (MG) is an autoimmune disease that is characterized by muscle weakness and fatigue. The role of the thymus in MG has been suggested by the evidence that 10% to 15% of patients present with a thymoma and at least 60% with thymus hyperplasia or dysplasia.Beneficial effects of thymectomy in patients with MG have been described in 40% to 90%.Few studies have looked at the incidence of reintubation (not just within 24 hours after extubation), the factors associated with reintubation, and patient outcome.

Premature extubation may lead to hypercarbia, hypoxemia, pulmonary hypertension, right heart failure, and myocardial ischemia. Additionally, it subjects the patient to the physical risks of reintubation, including esophageal intubation, laryngeal trauma, and pulmonary aspiration. The purpose of the present study was to determine the incidence of reintubation, the variables associated with reintubation, and patient outcome

Description:

Inclusion was based on the availability of all the following possible predictive pre-operative variables: age, gender, weight, height, body mass index, diabetes, creatinine, duration of MG, severity of MG (based on Osserman's classification), pathological type of MG, history of myasthenic crisis, dose of pyridostigmine, use of a steroid hormone, and use of an immunosuppressant.operative variables: postoperative pulmonary infection, total duration of hospital stay, duration of ICU stay, and duration of postoperative hospital stay. Variables were collected by research assistants and maintained in a computer database.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• younger than 75 years

• absence of heart failure as the primary indication for mechanical ventilation •Acute Physiology and Chronic Health Evaluation (APACHE) II score less than 12 points on day of extubation

• body mass index less than 30

Exclusion Criteria:

•preoperative moderate-to-severe chronic obstructive pulmonary disease

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Other:
• reintubation
Reintubation was defied by the reinstitution of invasive mechanical ventilation following extubation at any time

Locations

Country	Name	City	State
China	Genglong Liu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk Factors for Reintubation	the reintubation rate was analyzed with logistic regression	an average of 30 days