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CompletedNCT04247997Updated Jun 22, 2023

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

An interventional study of disconnect pulmonary vague nerve branches in Postoperative Chronic Cough, sponsored by Han Yuan. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Han Yuan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Chronic Cough

Keywords

  • postoperative chronic cough
  • pulmonary vagus nerve branch
  • autonomic nervous system
  • pulmonary nerves
  • thoracoscopic lobectomy
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 116 is above the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Han Yuan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    Group D

    disconnect pulmonary vague nerve branches

    Procedure: disconnect pulmonary vague nerve branches

  • No intervention
    Group P

    preserve the pulmonary vague nerve branches

Interventions

  • Proceduredisconnect 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after surgery

Secondary outcomes

  1. 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.

    Time frame: 1 month after surgery

  2. 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.

    Time frame: 1 month and 3 months after surgery

  3. Length of operation

    Time frame: during the operation

  4. volume of bleeding

    Time frame: during the operation

  5. volume of postoperative drainage

    Time frame: within 30 days after surgery

  6. the frequence of perioperative arrhythmia

    Time frame: during the operation

  7. the incidence of Postoperative complication

    pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident

    Time frame: within 30 days after surgery

  8. 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.

    Time frame: postoperative 1 day,2 days,3 days,4 days,5 days,6 days

  9. the time of extubation

    Time frame: within 30 days after surgery

  10. the incidence of gastrointestinal symptoms

    gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea

    Time frame: within 3 months after surgery

  11. the incidence of postoperative hospitalization

    Time frame: within 30 days after surgery

  12. pulmonary function 30 months after surgery

    maximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume

    Time frame: 30 months after surgery

07

Study locations

1 site
  • Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu 225000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04247997
Lead sponsor
Han Yuan
Responsible party
Han Yuan (Doctor-in-charge of Anesthetist, Xuzhou Medical University) — Sponsor-investigator
First posted
Jan 30, 2020
Start date
Feb 1, 2020
Primary completion
Nov 1, 2020
Completion
Feb 1, 2023
Last update
Jun 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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