Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476249
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-10
Brief Title:
Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection
Sponsor:
Hematology department of the 920th hospital
Organization:
Hematology department of the 920th hospital
Study Overview
Official Title:
A Prospective Cohort Study on Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None