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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04204148
Other study ID # 2019113
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date April 2020

Study information

Verified date December 2019
Source The First Affiliated Hospital of Soochow University
Contact Jun Zhao
Phone 13906130266
Email zhaojia0327@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (7)

Birring 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. Review. — View Citation

Brignall K, Jayaraman B, Birring SS. Quality of life and psychosocial aspects of cough. Lung. 2008;186 Suppl 1:S55-8. Epub 2007 Oct 16. Review. — View Citation

Dicpinigaitis PV, Rauf K. The influence of gender on cough reflex sensitivity. Chest. 1998 May;113(5):1319-21. — View Citation

Harle 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: 10.1 — View Citation

Koskela HO, Lätti 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). pii: 00113-2018. doi: 10.1183/23120541.00113-2018. eCollection 2018 Oct. — View Citation

Wang 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. — View Citation

Xie 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The day before surgery,two weeks after surgery,one month after surgery
Secondary Hospitalization days The numbers of days of patients stay in the hospital after surgery From the first days after surgery to discharge,up to 4 weeks
Secondary Drainage The total volume of fluid Measure the volume every 24 hours,up to 4 weeks
Secondary Anesthesia time Time from patient anesthesia to extubation Record total anesthesia during surgery
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