CoughNCT04204148
To Explore the Related Factors of Cough After Thoracoscopic Pneumonectomy
An observational study of Cough, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To explore the related factors of cough after Uniport video-assisted thoracoscopic surgery pneumonectomy, and to provide theoretical basis and social accumulation of new knowledge for the diagnosis and treatment of cough after pneumonectomy in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to Apr 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age ≥ 18 years old, male and female
Who may be able to join
- Age ≥ 18 years old, male and female
- Uniport video-assisted thoracoscopic surgery
- No cough symptoms within two weeks before operation
- Informed consent form was signed before operation
Who cannot join
- Diabetes , heart, brain, liver and kidney diseases
- Chest radiographs / CT in recent months indicate pneumonia
- Pulmonary function cannot tolerate lobectomy / segmental / cuneiform resection
- Distant metastasis patients
- Before operation, there were internal causes of cough (including respiratory tract infectious diseases, pharyngitis, allergic rhinitis, posterior nasal drip syndrome, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Chang Li, 15295666957, cli@suda.edu.cn
Liuying Pan, 17314947364, 757451025@qq.com
About this study
Official title: Multivariate Analysis of Cough After Uniport Video-assisted Thoracoscopic Surgery Pneumonectomy
To explore the related factors of cough after Uniport video-assisted thoracoscopic surgery pneumonectomy, and to provide theoretical basis and social accumulation of new knowledge for the diagnosis and treatment of cough after pneumonectomy in the future.
Read the detailed description
Intractable cough after thoracoscopic pneumonectomy is one of the common complications after pneumonectomy. The incidence of cough can reach 25% ≤ 50%. Cough after operation can aggravate the pain of incision, prolong the hospitalization time, increase the cost of hospitalization, affect the conversation and even sleep of the patients, increase the psychological burden of the patients, and reduce the quality of life of the patients accordingly. Therefore, through this study, the investigators hope to understand the related factors of cough after thoracoscopic pneumonectomy and whether there are predictable risk factors, so as to provide theoretical basis for reducing the occurrence of cough after pneumonectomy.
- Conditions
- Cough
- Keywords
- postoperative cough, Multivariate analysis, non-small cell lung cancer (NSCLC), Uniport Video-assisted Thoracoscopic Surgery
- Medical subject headings
- Cough, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical characteristics of the patients | including sex,age,smoking history,tumor location and tumor diameter | |
| Logistic regression analysis of influencing factors of c | The Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC) was used to evaluate the degree of cough in patients. The LCQ-MC is divided into three dimensions: physical, psychological and social. There are a total of 19 questions, and each question has seven options (positive scoring, grades 1-7; the higher the score is, the lighter the cough). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC) score before and after surgery
The Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC), which assesses the cough-related quality of life, consists of 19 items divided into three domains: the physical (8 items), psychological (7 items) and social (4 items) domains. A 7-point Likert scale was used to score individual domains. The total scores ranged from 3 to 21, with a higher score indicative of a better health status
Measured: The day before surgery,two weeks after surgery,one month after surgery
Secondary outcomes (3)
Hospitalization days
The numbers of days of patients stay in the hospital after surgery
Measured: From the first days after surgery to discharge,up to 4 weeks
Drainage
The total volume of fluid
Measured: Measure the volume every 24 hours,up to 4 weeks
Anesthesia time
Time from patient anesthesia to extubation
Measured: Record total anesthesia during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Dec 2019
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liping Peng, Principal investigator, The First Affiliated Hospital of Soochow UniversityLiuying Pan, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204148
- Sponsor's protocol ID
- 2019113
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dicpinigaitis PV, Rauf K. The influence of gender on cough reflex sensitivity. Chest. 1998 May;113(5):1319-21. doi: 10.1378/chest.113.5.1319.
PubMed 9596313Birring SS, Spinou A. How best to measure cough clinically. Curr Opin Pharmacol. 2015 Jun;22:37-40. doi: 10.1016/j.coph.2015.03.003. Epub 2015 Mar 25.
PubMed 25819594Harle ASM, Blackhall FH, Molassiotis A, Yorke J, Dockry R, Holt KJ, Yuill D, Baker K, Smith JA. Cough in Patients With Lung Cancer: A Longitudinal Observational Study of Characterization and Clinical Associations. Chest. 2019 Jan;155(1):103-113. doi: 10.1016/j.chest.2018.10.003. Epub 2018 Oct 13.
PubMed 30321508Brignall K, Jayaraman B, Birring SS. Quality of life and psychosocial aspects of cough. Lung. 2008;186 Suppl 1:S55-8. doi: 10.1007/s00408-007-9034-x. Epub 2007 Oct 16.
PubMed 17939003Xie MR, Zhu YF, Zhou MQ, Wu SB, Xu GW, Xu SB, Xu MQ. Analysis of factors related to chronic cough after lung cancer surgery. Thorac Cancer. 2019 Apr;10(4):898-903. doi: 10.1111/1759-7714.13021. Epub 2019 Mar 15.
PubMed 30875149Koskela HO, Latti AM, Pekkanen J. The impacts of cough: a cross-sectional study in a Finnish adult employee population. ERJ Open Res. 2018 Nov 12;4(4):00113-2018. doi: 10.1183/23120541.00113-2018. eCollection 2018 Oct.
PubMed 30443552Wang P, Zhu M, Zhang D, Guo XG, Zhao S, Zhang XL, Wang DL, Liu CT. The relationship between chronic obstructive pulmonary disease and non-small cell lung cancer in the elderly. Cancer Med. 2019 Aug;8(9):4124-4134. doi: 10.1002/cam4.2333. Epub 2019 Jun 11.
PubMed 31184445Pan LY, Peng LP, Xu C, Ding C, Chen J, Wang WY, Zhu XY, Zhao J, Li C. Predictive factors of cough after uniportal video-assisted thoracoscopic pulmonary resection. J Thorac Dis. 2020 Oct;12(10):5958-5969. doi: 10.21037/jtd-20-2652.
PubMed 33209428
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Analysis of Cough After Uniport Video-assisted Thoracoscopic Surgery Pneumonectomy
- ClinicalTrials.gov ID
- NCT04204148
- Acronym / sponsor ID
- 2019113
- Conditions
- Cough
- Keywords
- postoperative cough, Multivariate analysis, non-small cell lung cancer (NSCLC), Uniport Video-assisted Thoracoscopic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the related factors of cough after Uniport video-assisted thoracoscopic surgery pneumonectomy, and to provide theoretical basis and social accumulation of new knowledge for the diagnosis and treatment of cough after pneumonectomy in the future.
Detailed description
Intractable cough after thoracoscopic pneumonectomy is one of the common complications after pneumonectomy. The incidence of cough can reach 25% ≤ 50%. Cough after operation can aggravate the pain of incision, prolong the hospitalization time, increase the cost of hospitalization, affect the conversation and even sleep of the patients, increase the psychological burden of the patients, and reduce the quality of life of the patients accordingly. Therefore, through this study, the investigators hope to understand the related factors of cough after thoracoscopic pneumonectomy and whether there are predictable risk factors, so as to provide theoretical basis for reducing the occurrence of cough after pneumonectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical characteristics of the patients | – | –including sex,age,smoking history,tumor location and tumor diameter |
| Logistic regression analysis of influencing factors of c | – | –The Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC) was used to evaluate the degree of cough in patients. The LCQ-MC is divided into three dimensions: physical, psychological and social. There are a total of 19 questions, and each question has seven options (positive scoring, grades 1-7; the higher the score is, the lighter the cough). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years old, male and female
Key inclusion criteria (4 listed)
- Age ≥ 18 years old, male and female
- Uniport video-assisted thoracoscopic surgery
- No cough symptoms within two weeks before operation
- Informed consent form was signed before operation
Key exclusion criteria (5 listed)
- Diabetes , heart, brain, liver and kidney diseases
- Chest radiographs / CT in recent months indicate pneumonia
- Pulmonary function cannot tolerate lobectomy / segmental / cuneiform resection
- Distant metastasis patients
- Before operation, there were internal causes of cough (including respiratory tract infectious diseases, pharyngitis, allergic rhinitis, posterior nasal drip syndrome, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mean Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC) score before and after surgery
Time frame: The day before surgery,two weeks after surgery,one month after surgery
The Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC), which assesses the cough-related quality of life, consists of 19 items divided into three domains: the physical (8 items), psychological (7 items) and social (4 items) domains. A 7-point Likert scale was used to score individual domains. The total scores ranged from 3 to 21, with a higher score indicative of a better health status
3 secondary outcomes
Hospitalization days
Time frame: From the first days after surgery to discharge,up to 4 weeks
Drainage
Time frame: Measure the volume every 24 hours,up to 4 weeks
Anesthesia time
Time frame: Record total anesthesia during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Results publication: PubMed 9596313Dicpinigaitis PV, Rauf K. The influence of gender on cough reflex sensitivity. Chest. 1998 May;113(5):1319-21. doi: 10.1378/chest.113.5.1319.
- Results publication: PubMed 25819594Birring SS, Spinou A. How best to measure cough clinically. Curr Opin Pharmacol. 2015 Jun;22:37-40. doi: 10.1016/j.coph.2015.03.003. Epub 2015 Mar 25.
- Results publication: PubMed 30321508Harle ASM, Blackhall FH, Molassiotis A, Yorke J, Dockry R, Holt KJ, Yuill D, Baker K, Smith JA. Cough in Patients With Lung Cancer: A Longitudinal Observational Study of Characterization and Clinical Associations. Chest. 2019 Jan;155(1):103-113. doi: 10.1016/j.chest.2018.10.003. Epub 2018 Oct 13.
- Results publication: PubMed 17939003Brignall K, Jayaraman B, Birring SS. Quality of life and psychosocial aspects of cough. Lung. 2008;186 Suppl 1:S55-8. doi: 10.1007/s00408-007-9034-x. Epub 2007 Oct 16.
- Results publication: PubMed 30875149Xie MR, Zhu YF, Zhou MQ, Wu SB, Xu GW, Xu SB, Xu MQ. Analysis of factors related to chronic cough after lung cancer surgery. Thorac Cancer. 2019 Apr;10(4):898-903. doi: 10.1111/1759-7714.13021. Epub 2019 Mar 15.
- Results publication: PubMed 30443552Koskela HO, Latti AM, Pekkanen J. The impacts of cough: a cross-sectional study in a Finnish adult employee population. ERJ Open Res. 2018 Nov 12;4(4):00113-2018. doi: 10.1183/23120541.00113-2018. eCollection 2018 Oct.
- Results publication: PubMed 31184445Wang P, Zhu M, Zhang D, Guo XG, Zhao S, Zhang XL, Wang DL, Liu CT. The relationship between chronic obstructive pulmonary disease and non-small cell lung cancer in the elderly. Cancer Med. 2019 Aug;8(9):4124-4134. doi: 10.1002/cam4.2333. Epub 2019 Jun 11.
- Derived from this study: PubMed 33209428Pan LY, Peng LP, Xu C, Ding C, Chen J, Wang WY, Zhu XY, Zhao J, Li C. Predictive factors of cough after uniportal video-assisted thoracoscopic pulmonary resection. J Thorac Dis. 2020 Oct;12(10):5958-5969. doi: 10.21037/jtd-20-2652.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liping Peng principal investigator
The First Affiliated Hospital of Soochow University
Liuying Pan principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhao (13906130266, zhaojia0327@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean Leicester Cough Questionnaire in Mandarin Chinese (LCQ-MC) score before and after surgery (time frame: The day before surgery,two weeks after surgery,one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204148, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.