Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis

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

Study Overview

• Status: Unknown
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Other: reintubation

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 99

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Genglong Liu
      • Contact: Genglong Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with myasthenia gravis undergoing thymectomy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
reintubation; Reestablish of invasive mechanical ventilation	Other: reintubation; Reintubation was defied by the reinstitution of invasive mechanical ventilation following extubation at any time
not reintubation; Favourable respiratory function	Other: reintubation; Reintubation was defied by the reinstitution of invasive mechanical ventilation following extubation at any time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Factors for Reintubation	the reintubation rate was analyzed with logistic regression	an average of 30 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Genglong Liu, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Prediction; Reintubation; Myasthenia gravis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: Reintubation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No