Univent Tube for Thoracoscopic Thymectomy in Myasthenic Patients

NCT06101407 | Completed

• 1 other identifier: ĐHYHN168
• Study Type: observational
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myasthenia Gravis

Keywords

Univent tube; thoracoscopic thymectomy; myasthenia gravis; neuromuscular blocking agents

Outcome Measures

Primary Outcomes (7)

• 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 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

Secondary Outcomes (4)

• 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.

Study Arms (3)

MG stage I

MG stage IIA

MG stage IIB

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Myasthenia gravis patients
• Undergoing thoracoscopic thymectomy
• Undergoing general anesthesia

You may not qualify if:

• Mallampati IV
• Surgical complications

Sponsors & Collaborators

• Nguyen Dang Thu: lead
• Hanoi Medical University: collaborator

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 26, 2023
• Study Start: January 15, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 25, 2019
• Last Updated: October 26, 2023

Record last verified: 2023-10