NCT06101407|Completed
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Sponsor study identifier
observational
83
0 countries
N/A
Study Start
January 15, 2016
Actual (reported)Primary Completion
December 20, 2019
Actual (reported)Study Completion
December 25, 2019
Actual (reported)This observational study included consecutive MG patients who underwent thoracoscopic thymectomy with Univent tube intubation under general anesthesia without NMBAs and combined with airway topical anesthesia between January 2016 and December 2019. The investigators focus on intubation conditions, surgical conditions, intraoperative respiratory, and airway complications
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 25, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2016
Actual (reported)December 20, 2019
Actual (reported)December 25, 2019
Actual (reported)October 13, 2023
Actual (reported)October 26, 2023
Actual (reported)Rate of laryngoscopy difficulty
Laryngoscopy difficulties are categorized as: * easy * fair * difficult
During surgery
Rate of vocal cord position
Vocal cord positions are categorized as: * abducted * intermediate/moving * closed
During surgery
Rate of reaction to tracheal tube insertion and cuff inflation
Reaction to tracheal tube insertion and cuff inflation are evaluated based on diaphragmatic movement/coughing and categorized as: * none * slight * vigorous/sustained
During surgery
Rate of intubation conditions
Intubation conditions are categorized as: * excellent * good * poor
During surgery
Neuromuscular transmission at intubation time.
Neuromuscular transmission was measured using TOF value (%) at intubation time.
During surgery
Rate of vocal cord injuries
After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of bronchial injuries
After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of postoperative sore throat
After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of postoperative hoarseness
After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
MG patients who underwent thoracoscopic thymectomy under general anesthesia without NMBAs using Univent tube. MG was definitively diagnosed based on clinical features, electromyography results, and/or circulating antibodies against acetylcholine receptors and classified according to the Osserman Classification
83 participants (actual enrollment reported by the registry).
First Submitted
October 13, 2023
First Posted
October 26, 2023
Study Start
January 15, 2016
Actual (reported)Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis
Rate of lung collapse
During the surgical procedure, After opening the pleura and directly examining the quality of lung collapse as follows: 1. \- spontaneous 2. \- assisted with suction 3. \- manual
During surgery
Rate of surgical conditions
The surgical conditions, as evaluated by surgeons and categorized as: 1. \- excellent (complete collapse with perfect surgical exposure) 2. \- fair (total collapse, but the lung still has residual air) 3. \- poor (no collapse or partial collapse with interference in surgical exposure)
During surgery
Contact the study team to confirm eligibility.
Primary Completion
December 20, 2019
Actual (reported)Study Completion
December 25, 2019
Actual (reported)Last Updated
October 26, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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