Back to resultsEffect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy
Primary Purpose
Postoperative Chronic Cough
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
disconnect pulmonary vague nerve branches
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Chronic Cough focused on measuring postoperative chronic cough, pulmonary vagus nerve branch, autonomic nervous system, pulmonary nerves, thoracoscopic lobectomy
Eligibility Criteria
Inclusion Criteria:
- Patients with preoperative imaging of bronchial lung cancer below the secondary bronchus ,the maximum diameter of the tumor ≤ 5cm (T ≤ 2) and staging check not suggesting distant and mediastinal lymph node metastasis (N ≤ 1, M = 0) schedule to receive elective unilateral thoracoscopic lobectomy from 2019 to 2021 will be included in the trial.
- ASAⅠ-Ⅲ
Exclusion Criteria:
- Chronic cough (>8 weeks), its causes including chronic bronchitis, asthma, gastroesophageal reflux disease, history of postnasal drip syndrome, and the use of ACEI drugs and so on;
- other history of lung surgery;
- patients with severe arrhythmia;
- there are contraindications for anesthesia and surgery;
- pregnancy and lactation.
Sites / Locations
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group D
Group P
Arm Description
disconnect pulmonary vague nerve branches
preserve the pulmonary vague nerve branches
Outcomes
Primary Outcome Measures
The incidence of chronic cough after surgery
More than 8 weeks after surgery, there is no clear cause of cough with stable chest CT excluding the diagnosis of postnasal drip syndrome, asthma or the use of Angiotensin-converting enzyme inhibitor(ACEI), etc.
Secondary Outcome Measures
The incidence of chronic cough after surgery
More than 8 weeks after surgery, there is no clear cause of cough with stable chest CT excluding the diagnosis of postnasal drip syndrome, asthma or the use of Angiotensin-converting enzyme inhibitor(ACEI), etc.
The score of the LCQ-MC scale after surgery
The LCQ-MC was designed for the assessment of a chronic cough, consists of 19 items and three domains.
Length of operation
volume of bleeding
volume of postoperative drainage
the frequence of perioperative arrhythmia
the incidence of Postoperative complication
pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident
the score of Cough symptom
The score was used to record daily symptom score for cough severity.The scale is scored by 4 levels at day and night respectively.The higher score means worse symptom.
the time of extubation
the incidence of gastrointestinal symptoms
gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea
the incidence of postoperative hospitalization
pulmonary function 30 months after surgery
maximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04247997
Brief Title
Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy
Official Title
Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Yuan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to determine whether disconnecting pulmonary vagus nerve branch can abatement chronic cough in patients undergoing unilateral thoracoscopic lobectomy,compared with preserving pulmonary vagus nerve branch.
Detailed Description
After screening for the Inclusion criteria and the exclusion criteria, 116 patients undergoing unilateral thoracoscopic lobectomy are randomly assigned to two groups, disconnecting pulmonary vague nerve branches and preserving pulmonary vague nerve branches. The incidence of chronic cough after surgery is compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Chronic Cough
Keywords
postoperative chronic cough, pulmonary vagus nerve branch, autonomic nervous system, pulmonary nerves, thoracoscopic lobectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group D
Arm Type
Experimental
Arm Description
disconnect pulmonary vague nerve branches
Arm Title
Group P
Arm Type
No Intervention
Arm Description
preserve the pulmonary vague nerve branches
Intervention Type
Procedure
Intervention Name(s)
disconnect pulmonary vague nerve branches
Intervention Description
When the operation is in the right side, the Azygous vein bow is used as the marker, and in the left side, the aortic arch is used as the marker to identify the vagus nerve trunk.Then the surgeons dissect the vagus nerve trunk. This is used as a clue to find the vagus nerve pulmonary branch leading to the hilum. The position of the detachment is after the anterior and posterior pulmonary branches of the vagus nerve separating from the trunk and before the formation of the lung plexus.
Primary Outcome Measure Information:
Title
The incidence of chronic cough after surgery
Description
More than 8 weeks after surgery, there is no clear cause of cough with stable chest CT excluding the diagnosis of postnasal drip syndrome, asthma or the use of Angiotensin-converting enzyme inhibitor(ACEI), etc.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
The incidence of chronic cough after surgery
Description
More than 8 weeks after surgery, there is no clear cause of cough with stable chest CT excluding the diagnosis of postnasal drip syndrome, asthma or the use of Angiotensin-converting enzyme inhibitor(ACEI), etc.
Time Frame
1 month after surgery
Title
The score of the LCQ-MC scale after surgery
Description
The LCQ-MC was designed for the assessment of a chronic cough, consists of 19 items and three domains.
Time Frame
1 month and 3 months after surgery
Title
Length of operation
Time Frame
during the operation
Title
volume of bleeding
Time Frame
during the operation
Title
volume of postoperative drainage
Time Frame
within 30 days after surgery
Title
the frequence of perioperative arrhythmia
Time Frame
during the operation
Title
the incidence of Postoperative complication
Description
pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident
Time Frame
within 30 days after surgery
Title
the score of Cough symptom
Description
The score was used to record daily symptom score for cough severity.The scale is scored by 4 levels at day and night respectively.The higher score means worse symptom.
Time Frame
postoperative 1 day,2 days,3 days,4 days,5 days,6 days
Title
the time of extubation
Time Frame
within 30 days after surgery
Title
the incidence of gastrointestinal symptoms
Description
gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea
Time Frame
within 3 months after surgery
Title
the incidence of postoperative hospitalization
Time Frame
within 30 days after surgery
Title
pulmonary function 30 months after surgery
Description
maximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume
Time Frame
30 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with preoperative imaging of bronchial lung cancer below the secondary bronchus ,the maximum diameter of the tumor ≤ 5cm (T ≤ 2) and staging check not suggesting distant and mediastinal lymph node metastasis (N ≤ 1, M = 0) schedule to receive elective unilateral thoracoscopic lobectomy from 2019 to 2021 will be included in the trial.
ASAⅠ-Ⅲ
Exclusion Criteria:
Chronic cough (>8 weeks), its causes including chronic bronchitis, asthma, gastroesophageal reflux disease, history of postnasal drip syndrome, and the use of ACEI drugs and so on;
other history of lung surgery;
patients with severe arrhythmia;
there are contraindications for anesthesia and surgery;
pregnancy and lactation.
Facility Information:
Facility Name
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy
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