To Explore the Related Factors of Cough After Thoracoscopic Pneumonectomy

December 17, 2019 updated by: The First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

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 Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
        • 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Age ≥ 18 years old, male and female

Description

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 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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The day before surgery,two weeks after surgery,one month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization days
Time Frame: From the first days after surgery to discharge,up to 4 weeks
The numbers of days of patients stay in the hospital after surgery
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
The total volume of fluid
Measure the volume every 24 hours,up to 4 weeks
Anesthesia time
Time Frame: Record total anesthesia during surgery
Time from patient anesthesia to extubation
Record total anesthesia during surgery

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Liping Peng, The First Affiliated Hospital of Soochow University
  • Principal Investigator: Liuying Pan, The First Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

December 14, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019113

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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