Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03597373
Other study ID # Reintubation
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05039190 - Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients Phase 3
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT01727193 - The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy Phase 3
Completed NCT00285350 - Mycophenolate Mofetil in Myasthenia Gravis Phase 3
Recruiting NCT05890833 - The Risk of Falls Index for Patients With Neuromuscular Disorders
Completed NCT05694234 - Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Not yet recruiting NCT05095103 - Immune Profiles in Myasthenia Gravis
Not yet recruiting NCT04965987 - Oxaloacetate in Myasthenia Gravis Phase 1
Terminated NCT02102594 - Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) Phase 2
Completed NCT02066519 - Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis N/A
Completed NCT02774239 - A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) Phase 3
Completed NCT02118805 - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Terminated NCT01828294 - Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis Phase 1
Terminated NCT00727194 - Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis Phase 2
Completed NCT04590716 - Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
Recruiting NCT04837625 - Study of Myasthenic Crisis in China
Not yet recruiting NCT01469858 - Perception and Multisensory Integration in Neurological Patients Using fMRI N/A
Completed NCT05408702 - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Completed NCT03205306 - Myasthenia Gravis and Psyche