Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection

June 26, 2024 updated by: Hematology department of the 920th hospital

A Prospective Cohort Study on Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection

Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. Pulmonary resection is the most applicable to early-stage lung cancer diagnoses and considered the best curative options. Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. This study is a prospective observational study and is expected to be carried out in a large tertiary hospital. This cohort is expected to include 1000 participants for three years.

Patients with pulmonary nodules on chest CT will be divided into two groups based on the presence or absence of cough symptoms on admission. The investigators decided whether to include patients in this cohort study strictly based on the inclusion and exclusion criteria. The severity of cough, the trajectory of cough change, and the physiological and social burden caused by cough will be reflected by the results of LCQ-MC, CSS, HARQ, and VAS. LCQ-MC, CSS, HARQ, and VAS are just a few of the questionnaires that are widely used to investigate the cough and severity of the respondent. The included variables included age, gender, Height, Weight, education level, smoking history, alcohol history, preoperative lung function, nodule size, preoperative and postoperative blood routine (such as white blood cell count, neutrophil count, etc.), blood biochemistry (such as C-reactive protein, PCT, etc.), liver and kidney function test results, surgical method, surgical site, operation duration, anesthesia method, anesthesia duration, lymph node dissection, pathological results, chest tube caliber, number of days of catheterization, use of cough drugs, use of non-steroidal anti-inflammatory drugs, Number of days in hospital and number of outpatient visits due to cough.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. With the continuous updating of medical equipment and the gradual popularization of lung cancer screening, the detection rate of pulmonary nodules has been greatly improved, and surgical treatment is still the main treatment method for high-risk pulmonary nodules. Pulmonary resection, including wedge resection, segmentectomy and lobectomy, is the most applicable to early-stage lung cancer diagnoses and considered the best curative options.

Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. Persistent cough after pulmonary resection is defined as follows: non-productive cough that occurs more than 2 weeks after pulmonary resection with stable chest roentgenogram results, no evidence of postnasal drip syndrome or asthma, and no angiotensin converting enzyme inhibitor administration. Severe and persistent cough not only increases the difficulty of postoperative lung function exercise for patients, affects the recovery of the surgical site, but also affects their daily life and sleep, increases their physiological and psychological burden, and causes a huge social burden.

However, the reason why cough after pulmonary resection occurs is steal unclear.

CAP can be induced by various factors. According to previous studies, these factors are classified into four types: surgical factors, anesthetic factors, chemical factors, and other factors. The majority studies focus on the surgical factors, and have some points on the risk factors. Several small size studies suggested that mediastinal lymph node dissection may be an independent risk factor for persistent cough after Some studies previously reported that some factors, including surgical factors and gastroesophageal reflux (GER) secondary to the loss of volume after pulmonary resection, may be risky for persistent cough after pulmonary resection.

Vagus nerves and their branches mainly assume the afferent activities arising from sensory terminals which located in the lung and airway. And a vast majority of Vagus nerves and their branches are non-myelinated (C-) fibers.

Under normal or abnormal physiological conditions, the C-fiber locating in the lung and airway plays an important role in regulating the cardiopulmonary functions.

It is extensively documented that the sensitivity of vagal bronchopulmonary C-fibers can be enhanced by injury or inflammation of airway mucosa during both acute and chronic airway diseases. Actually, all afferent C fibers in both the somatosensory and visceral nervous systems can be stimulated by chemical mediators associated with inflammation. Some scholars speculate that it may be related to C-type fibers and inflammatory factors introduced by the vagus nerve. In basic experimental research, DP1, IP, EP1, and EP2 receptors are expressed in C fiber neurons.

This prospective cohort study will describe the incidence of CAP and the trajectory change in cough severity in patients with thoracoscopic lung resection. The primary objective of the study is to explore the risk factors for the development of CAP and to assess the physical, psychological, social, and life burdens of patients with CAP. The secondary objective is to see if the use of nonsteroidal drugs has an effect on the development of CAP. This study aims to provide preliminary evidence and guidance on appropriate treatment of post-pneumonectomy cough and risk factors for persistent cough and non-steroidal pharmacotherapy for CAP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 223964
        • Recruiting
        • the 920th Hospital of the Joint Logistics Support Force
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants in this study are from the 920th Hospital. Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.

Description

Inclusion Criteria:

● Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.

Exclusion Criteria:

  • Pre-existing cough before surgery (e.g. asthma, taking ACEI Drugs, etc.)
  • Distant metastasis of tumor
  • Combined pregnancy or breastfeeding
  • Combined with other systemic major diseases (such as malignant swelling, chronic liver insufficiency, chronic renal insufficiency, etc.)
  • Suffering from mental illness
  • Refusal of follow-up or incomplete clinical information
  • Poor compliance and other groups considered by the investigator not suitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
cough
Patients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy with postoperative cough
Other: without
without
Uncough
Patients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy without postoperative cough
Other: without
without

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The score value of Mandarin Chinese version of the Leicester Cough Questionnaire
Time Frame: On the 3rd,1 month and Half a year postoperatively
Mandarin Chinese version of the Leicester Cough Questionnaire is a globally recognized questionnaire for assessing the severity of cough
On the 3rd,1 month and Half a year postoperatively
The score value of visual analogue scale
Time Frame: On the 3rd, 7th, 11th, 15th, 1 month, and half a year after surgery, respectively
The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough
On the 3rd, 7th, 11th, 15th, 1 month, and half a year after surgery, respectively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The score value of Hull airway reflux questionnaire
Time Frame: On the 3rd,1 month and Half a year postoperatively
The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough
On the 3rd,1 month and Half a year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hematology department of the 920th hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Wenk Cai, doctor, the Vice-President of the 920th Hospital of the Joint Logistics Support Force

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202404101CAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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