Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy

Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Chronic Cough
• Intervention / Treatment: Procedure: disconnect pulmonary vague nerve branches

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 225000
      • Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D; disconnect pulmonary vague nerve branches	Procedure: disconnect pulmonary vague nerve branches; 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.; Other Names: preserve the pulmonary vague nerve branches
No Intervention: Group P; preserve the pulmonary vague nerve branches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after surgery
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.	1 month and 3 months after surgery
Length of operation		during the operation
volume of bleeding		during the operation
volume of postoperative drainage		within 30 days after surgery
the frequence of perioperative arrhythmia		during the operation
the incidence of Postoperative complication	pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident	within 30 days after surgery
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.	postoperative 1 day,2 days,3 days,4 days,5 days,6 days
the time of extubation		within 30 days after surgery
the incidence of gastrointestinal symptoms	gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea	within 3 months after surgery
the incidence of postoperative hospitalization		within 30 days after surgery
pulmonary function 30 months after surgery	maximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume	30 months after surgery

Collaborators and Investigators

• Sponsor: Han Yuan

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: autonomic nervous system; postoperative chronic cough; pulmonary vagus nerve branch; pulmonary nerves; thoracoscopic lobectomy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: XYFY2019-KL179-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No