Myasthenia Gravis Associated With ThymomaNCT03468452
Early Versus Late Extubation in Myasthenia Gravis Patients
An observational study of Myasthenia Gravis Associated With Thymoma, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis Associated With Thymoma
- What is being tested?
- extubation
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 11 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: after thymectomy in patients with myasthenia gravis
Who may be able to join
- myasthenia gravis patients after thymectomy
Who cannot join
- not extubation
About this study
Official title: Early Versus Late Extubation After Thymectomy in Patients With Myasthenia Gravis: A Retrospective Analysis
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.
Read the 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.
- Being tested
- extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extubationOther
Time of extubation
| Study group | Role | What they receive |
|---|---|---|
| Early extubation | The endotracheal tube is removed in the operation room, and no suction support is required after surgery. Receives: Other: extubation | |
| late extubation | Take the tracheal tube back to the ward for respiratory support or removal of air.
The catheter is inserted again within 48h. Receives: Other: extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU stay
Record the time spent in hospital for each patient
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jan 2015
- Primary completion21 Nov 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis Associated With ThymomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhenguang Chen, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468452
- Sponsor's protocol ID
- Timing of Extubation
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Extubation After Thymectomy in Patients With Myasthenia Gravis: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03468452
- Acronym / sponsor ID
- Timing of Extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early extubation | – | Other: extubationThe endotracheal tube is removed in the operation room, and no suction support is required after surgery. |
| late extubation | – | Other: extubationTake the tracheal tube back to the ward for respiratory support or removal of air. The catheter is inserted again within 48h. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- after thymectomy in patients with myasthenia gravis
Key inclusion criteria (1 listed)
- myasthenia gravis patients after thymectomy
Key exclusion criteria (1 listed)
- not extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extubationTime of extubation | Other | Early extubation, late extubation |
Primary outcome
Length of ICU stay
Time frame: through study completion, an average of 1 year
Record the time spent in hospital for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenguang Chen study chair
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis Associated With Thymoma, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU stay (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.