Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03597373
Collaborator
(none)
99
1
24
4.1

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
99 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Risk Factors for Reintubation [an average of 30 days]

    the reintubation rate was analyzed with logistic regression

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Genglong Liu Guangzhou Guangdong China 510080

Sponsors and Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Genglong Liu, 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:
NCT03597373
Other Study ID Numbers:
  • Reintubation
First Posted:
Jul 24, 2018
Last Update Posted:
Jul 24, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GengLong Liu, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2018