Myasthenia GravisNCT06101407
Univent Tube for Thoracoscopic Thymectomy in Myasthenic Patients
An observational study of Myasthenia Gravis, run by Nguyen Dang Thu.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 25 Dec 2019
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Myasthenia gravis patients
- Undergoing thoracoscopic thymectomy
- Undergoing general anesthesia
Who cannot join
- Mallampati IV
- Surgical complications
About this study
Official title: Univent Tube for Thoracoscopic Thymectomy in Myasthenic Patients: an Observational Study
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
Read the detailed description
This prospective study was conducted on MG patients who underwent thoracoscopic thymectomy under general anesthesia without NMBAs using Univent tube at Vietnam Military Hospital 103 from January 2016 to December 2019. MG was definitively diagnosed based on clinical features, electromyography results, and/or circulating antibodies against acetylcholine receptors and classified according to the Osserman Classification. Preoperative evaluations included CT scans, pulmonary function tests, and routine exams. The operative risk and airway assessments were evaluated by expert anesthesiologists and excluded patients with preexisting hoarseness or sore throat. This study was approved by Hanoi Medical University's ethics committee (No.168-QĐ/ĐHYHN) and Military Hospital 103. All patients were anesthetized and intubated by one anesthesiologist assigned to the thoracic surgery unit.
Anesthesia procedure
In the operating theatre, the standard monitoring included electrocardiogram (ECG), invasive arterial blood pressure (IABP), peripheral oxygen saturation (SpO2), end-tidal capnography (EtCO2), ventilation peak and plateau pressures, continuous spirometry, and entropy (response entropy-RE and state entropy-SE; Datex Omeda S/5 Advance, GE, USA). Neuromuscular monitoring was recorded in the left forearm using TOF (train-of-four)-WatchsSX (Organons, Oss, the Netherlands).
Patients were pre-oxygenated with 100% oxygen for 5 minutes before induction with sufentanil at 0.5 µg.kg-1 and propofol at 2-3 mg.kg-1. When patients lost their eyelash reflex, lidocaine 10% was initially sprayed in the oral cavity, oropharynx, and upper part of the larynx. Subsequently, lidocaine 2% was administered using The MADgic Laryngo-Tracheal Mucosal Atomization Device (Teleflex, Wayne, Pennsylvania, USA) to cover the oral cavity, oropharynx, larynx, vocal cords, and as deep as possible into the trachea.
Once the SE value reached 50 or lower, a Univent tube (Fuji Systems, Tokyo, Japan) was intubated using conventional direct laryngoscopy. The tube size was standardized based on the patient's sex, with an 8.0-mm inner diameter (ID) used for men and a 7.0-mm ID used for women. Depending on the side of the chest for approaching the anterior mediastinum, the endobronchial blocker was carefully guided into either the right (for a right-sided approach) or left mainstem bronchus (for a left-sided approach) using flexible fiberoptic bronchoscopy. The tracheal and blocker cuffs were gently inflated, ensuring that the intracuff pressure stayed below 30 cmH2O, as measured by a noninvasive manometer. Following the secure positioning of patients in a 45° lateral decubitus orientation for surgery, with their heads firmly fixed, the correct placement of the blocker was reassessed through bronchoscopy.
Anesthesia maintenance was guided by Entropy, utilizing either propofol TCI or sevoflurane to keep the SE index within the 40-60 range throughout the surgical procedure. Additionally, a continuous infusion of sufentanil at 0.2 µg.kg-1.hr-1 was administered, and the patient's temperature was carefully regulated with a heating blanket.
For two-lung ventilation, the ventilator was initially set in A/C mode (FiO2 = 60%, respiratory rate of 14 breaths.min-1, tidal volume of 8-10 ml.kg-1, inspiration-expiration ratio of 1:2). When establishing one-lung ventilation, investigators adjusted the tidal volume (to 5-7 ml.kg-1) and respiratory rate to maintain EtCO2 between 35-40 mmHg and Ppeak < 35 cmH2O; oxygen was given at 100% and gradually reduced by 10% while aiming for SpO2 > 95%. Trocars were placed and the tumor was dissected and removed. Following the insertion of the drainage tube, the collapsed lung was inflated and re-ventilated at the end of the surgery. Patients meeting extubation criteria were extubated in the operating room; otherwise, they were transferred to the postoperative care unit.
Data collection and criteria
Characteristics of the study population included demographic data (age, gender, BMI), disease characteristics (classification, disease duration, symptoms, diagnostic tests), laboratory data, preoperative pulmonary function status, surgical characteristics (tumor features, surgical side), and duration of surgery and anesthesia.
Intubating conditions and intubating variables
The intubating score was assessed following the consensus conference guidelines on Good Clinical Research Practice in Pharmacodynamic Studies of Neuromuscular Blocking Agents. This evaluation included laryngoscopy difficulty (categorized as easy, fair, or difficult), vocal cord position (described as abducted, intermediate/moving, or closed), and the patient's reaction to tracheal tube insertion and cuff inflation (evaluated based on diaphragmatic movement/coughing, categorized as none, slight, or vigorous/sustained). These criteria were used to assign an overall intubation condition score of excellent, good, or poor.
Additionally, the following intubation-related variables were recorded: Mallampati score, mask ventilation categorized as "easy" (successful mask ventilation with or without an oral airway), "difficult" (inadequate or unstable ventilation, requiring two practitioners), or "impossible" (unable to ventilate without a muscle relaxant), the number of intubation attempts, the time required for intubation and bronchial blocker placement (measured in seconds, from the start of laryngoscopy to successful bronchial blocker positioning), and the TOF (train-of-four) value at the time of intubation (%).
Device conditions and surgical variables
During the surgical procedure, the malposition of the bronchial blocker were noted. After opening the pleura and directly examining the lungs, the quality of lung collapse were recorded as follows: 1 - spontaneous; 2 - assisted with suction; or 3 - manual. The surgeon was asked to provide an overall assessment of lung isolation and rated the surgical conditions as follows: 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).
Respiratory evaluations
The lung mechanical ventilation parameters, oxygenation, and capnography parameters were documented. Arterial blood gas analysis was also performed during two-lung ventilation and after 30 minutes of one-lung ventilation. Hypoxemia during surgery was defined as a drop in SpO2 below 90% at any point during the intraoperative period.
Postoperative airway injuries, sore throat, and hoarseness After surgery, all patients underwent bronchoscopy examination while still under anesthesia to assess their bronchial lesions. Following successful extubation, a flexible laryngoscopy was performed to evaluate potential vocal cord injuries. Results from both examinations were recorded and analyzed by an experienced ear, nose, and throat specialist. Airway injuries were classified as redness, edema, or hematoma.
Postoperative sore throat and hoarseness were assessed immediately after anesthesia emergence and on days 1, 2, and 3 post-surgeries. Sore throat was defined as continuous throat pain and postoperative hoarseness was categorized as a change in acoustic quality from the patient's previous voice (yes or no). Daily follow-up examinations were conducted until complete resolution.
- Conditions
- Myasthenia Gravis
- Keywords
- Univent tube, thoracoscopic thymectomy, myasthenia gravis, neuromuscular blocking agents
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MG stage I | Not described | |
| MG stage IIA | Not described | |
| MG stage IIB | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of laryngoscopy difficulty
Laryngoscopy difficulties are categorized as:
- easy
- fair
- difficult
Measured: During surgery
Rate of vocal cord position
Vocal cord positions are categorized as:
- abducted
- intermediate/moving
- closed
Measured: 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
Measured: During surgery
Rate of intubation conditions
Intubation conditions are categorized as:
- excellent
- good
- poor
Measured: During surgery
Neuromuscular transmission at intubation time.
Neuromuscular transmission was measured using TOF value (%) at intubation time.
Measured: During surgery
Rate of lung collapse
During the surgical procedure, After opening the pleura and directly examining the quality of lung collapse as follows:
- - spontaneous
- - assisted with suction
- - manual
Measured: During surgery
Rate of surgical conditions
The surgical conditions, as evaluated by surgeons and categorized as:
- - excellent (complete collapse with perfect surgical exposure)
- - fair (total collapse, but the lung still has residual air)
- - poor (no collapse or partial collapse with interference in surgical exposure)
Measured: During surgery
Secondary outcomes (4)
Rate of vocal cord injuries
classified as:
- redness
- edema
- hematoma
Measured: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of bronchial injuries
classified as:
- redness
- edema
- hematoma
Measured: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of postoperative sore throat
Sore throat was defined as continuous throat pain (yes or no).
Measured: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of postoperative hoarseness
Hoarseness was categorized as a change in acoustic quality from the patient's previous voice (yes or no)
Measured: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start15 Jan 2016
- Primary completion20 Dec 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Dang Thu
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University
- Responsible party
- Sponsor-investigator, Nguyen Dang Thu, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101407
- Sponsor's protocol ID
- ĐHYHN168
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Univent Tube for Thoracoscopic Thymectomy in Myasthenic Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT06101407
- Acronym / sponsor ID
- ĐHYHN168
- Conditions
- Myasthenia Gravis
- Keywords
- Univent tube, thoracoscopic thymectomy, myasthenia gravis, neuromuscular blocking agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Nguyen Dang ThuUniversity, hospital or other
- Collaborators
- Hanoi Medical University
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 26 Oct 2023 (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.
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
Detailed description
This prospective study was conducted on MG patients who underwent thoracoscopic thymectomy under general anesthesia without NMBAs using Univent tube at Vietnam Military Hospital 103 from January 2016 to December 2019. MG was definitively diagnosed based on clinical features, electromyography results, and/or circulating antibodies against acetylcholine receptors and classified according to the Osserman Classification. Preoperative evaluations included CT scans, pulmonary function tests, and routine exams. The operative risk and airway assessments were evaluated by expert anesthesiologists and excluded patients with preexisting hoarseness or sore throat. This study was approved by Hanoi Medical University's ethics committee (No.168-QĐ/ĐHYHN) and Military Hospital 103. All patients were anesthetized and intubated by one anesthesiologist assigned to the thoracic surgery unit.
Anesthesia procedure
In the operating theatre, the standard monitoring included electrocardiogram (ECG), invasive arterial blood pressure (IABP), peripheral oxygen saturation (SpO2), end-tidal capnography (EtCO2), ventilation peak and plateau pressures, continuous spirometry, and entropy (response entropy-RE and state entropy-SE; Datex Omeda S/5 Advance, GE, USA). Neuromuscular monitoring was recorded in the left forearm using TOF (train-of-four)-WatchsSX (Organons, Oss, the Netherlands).
Patients were pre-oxygenated with 100% oxygen for 5 minutes before induction with sufentanil at 0.5 µg.kg-1 and propofol at 2-3 mg.kg-1. When patients lost their eyelash reflex, lidocaine 10% was initially sprayed in the oral cavity, oropharynx, and upper part of the larynx. Subsequently, lidocaine 2% was administered using The MADgic Laryngo-Tracheal Mucosal Atomization Device (Teleflex, Wayne, Pennsylvania, USA) to cover the oral cavity, oropharynx, larynx, vocal cords, and as deep as possible into the trachea.
Once the SE value reached 50 or lower, a Univent tube (Fuji Systems, Tokyo, Japan) was intubated using conventional direct laryngoscopy. The tube size was standardized based on the patient's sex, with an 8.0-mm inner diameter (ID) used for men and a 7.0-mm ID used for women. Depending on the side of the chest for approaching the anterior mediastinum, the endobronchial blocker was carefully guided into either the right (for a right-sided approach) or left mainstem bronchus (for a left-sided approach) using flexible fiberoptic bronchoscopy. The tracheal and blocker cuffs were gently inflated, ensuring that the intracuff pressure stayed below 30 cmH2O, as measured by a noninvasive manometer. Following the secure positioning of patients in a 45° lateral decubitus orientation for surgery, with their heads firmly fixed, the correct placement of the blocker was reassessed through bronchoscopy.
Anesthesia maintenance was guided by Entropy, utilizing either propofol TCI or sevoflurane to keep the SE index within the 40-60 range throughout the surgical procedure. Additionally, a continuous infusion of sufentanil at 0.2 µg.kg-1.hr-1 was administered, and the patient's temperature was carefully regulated with a heating blanket.
For two-lung ventilation, the ventilator was initially set in A/C mode (FiO2 = 60%, respiratory rate of 14 breaths.min-1, tidal volume of 8-10 ml.kg-1, inspiration-expiration ratio of 1:2). When establishing one-lung ventilation, investigators adjusted the tidal volume (to 5-7 ml.kg-1) and respiratory rate to maintain EtCO2 between 35-40 mmHg and Ppeak < 35 cmH2O; oxygen was given at 100% and gradually reduced by 10% while aiming for SpO2 > 95%. Trocars were placed and the tumor was dissected and removed. Following the insertion of the drainage tube, the collapsed lung was inflated and re-ventilated at the end of the surgery. Patients meeting extubation criteria were extubated in the operating room; otherwise, they were transferred to the postoperative care unit.
Data collection and criteria
Characteristics of the study population included demographic data (age, gender, BMI), disease characteristics (classification, disease duration, symptoms, diagnostic tests), laboratory data, preoperative pulmonary function status, surgical characteristics (tumor features, surgical side), and duration of surgery and anesthesia.
Intubating conditions and intubating variables
The intubating score was assessed following the consensus conference guidelines on Good Clinical Research Practice in Pharmacodynamic Studies of Neuromuscular Blocking Agents. This evaluation included laryngoscopy difficulty (categorized as easy, fair, or difficult), vocal cord position (described as abducted, intermediate/moving, or closed), and the patient's reaction to tracheal tube insertion and cuff inflation (evaluated based on diaphragmatic movement/coughing, categorized as none, slight, or vigorous/sustained). These criteria were used to assign an overall intubation condition score of excellent, good, or poor.
Additionally, the following intubation-related variables were recorded: Mallampati score, mask ventilation categorized as "easy" (successful mask ventilation with or without an oral airway), "difficult" (inadequate or unstable ventilation, requiring two practitioners), or "impossible" (unable to ventilate without a muscle relaxant), the number of intubation attempts, the time required for intubation and bronchial blocker placement (measured in seconds, from the start of laryngoscopy to successful bronchial blocker positioning), and the TOF (train-of-four) value at the time of intubation (%).
Device conditions and surgical variables
During the surgical procedure, the malposition of the bronchial blocker were noted. After opening the pleura and directly examining the lungs, the quality of lung collapse were recorded as follows: 1 - spontaneous; 2 - assisted with suction; or 3 - manual. The surgeon was asked to provide an overall assessment of lung isolation and rated the surgical conditions as follows: 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).
Respiratory evaluations
The lung mechanical ventilation parameters, oxygenation, and capnography parameters were documented. Arterial blood gas analysis was also performed during two-lung ventilation and after 30 minutes of one-lung ventilation. Hypoxemia during surgery was defined as a drop in SpO2 below 90% at any point during the intraoperative period.
Postoperative airway injuries, sore throat, and hoarseness After surgery, all patients underwent bronchoscopy examination while still under anesthesia to assess their bronchial lesions. Following successful extubation, a flexible laryngoscopy was performed to evaluate potential vocal cord injuries. Results from both examinations were recorded and analyzed by an experienced ear, nose, and throat specialist. Airway injuries were classified as redness, edema, or hematoma.
Postoperative sore throat and hoarseness were assessed immediately after anesthesia emergence and on days 1, 2, and 3 post-surgeries. Sore throat was defined as continuous throat pain and postoperative hoarseness was categorized as a change in acoustic quality from the patient's previous voice (yes or no). Daily follow-up examinations were conducted until complete resolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MG stage I | – | – |
| MG stage IIA | – | – |
| MG stage IIB | – | – |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Myasthenia gravis patients
- Undergoing thoracoscopic thymectomy
- Undergoing general anesthesia
Key exclusion criteria (2 listed)
- Mallampati IV
- Surgical complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of laryngoscopy difficulty
Time frame: During surgery
Laryngoscopy difficulties are categorized as: * easy * fair * difficult
Rate of vocal cord position
Time frame: During surgery
Vocal cord positions are categorized as: * abducted * intermediate/moving * closed
Rate of reaction to tracheal tube insertion and cuff inflation
Time frame: During surgery
Reaction to tracheal tube insertion and cuff inflation are evaluated based on diaphragmatic movement/coughing and categorized as: * none * slight * vigorous/sustained
Rate of intubation conditions
Time frame: During surgery
Intubation conditions are categorized as: * excellent * good * poor
Neuromuscular transmission at intubation time.
Time frame: During surgery
Neuromuscular transmission was measured using TOF value (%) at intubation time.
Rate of lung collapse
Time frame: During surgery
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
Rate of surgical conditions
Time frame: During surgery
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)
4 secondary outcomes
Rate of vocal cord injuries
Time frame: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of bronchial injuries
Time frame: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of postoperative sore throat
Time frame: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
Rate of postoperative hoarseness
Time frame: After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.
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 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Nguyen Dang Thu.
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 3 inclusion and 2 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 26 Oct 2023. 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?
Rate of laryngoscopy difficulty (time frame: During surgery). The study lists 7 primary outcomes in all. 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 26 Oct 2023.