- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05131009
Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas
November 10, 2021 updated by: Wuhan Union Hospital, China
Differences in Incidence and Risk Factors of Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas
This study aims to collect perioperative diagnosis and treatment information of patients undergoing abdominal surgery at plateau and plain areas , collect blood and others samples for laboratory testing when necessary, analyzing the data to clarify the incidence and risk factors of pulmonary complications in patients undergoing abdominal surgery at different altitudes, so as to reduce the risk of pulmonary complications and even death in clinical practice.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Anticipated)
600
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
- Name: Qingping Wu, Professor
- Phone Number: 13971605283
- Email: wqp1968@163.com
Study Locations
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Hubei
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Wuhan, Hubei, China, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Qingping Wu
- Email: wqp1968@163.com
-
-
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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients aged 18 years or older who planned elective abdominal surgery under general anesthesia
Description
Inclusion Criteria:
- ≥ 18 years old;
- scheduled for elective abdominal surgery under general anesthesia;
- ASAⅠ-Ⅲ
Exclusion Criteria:
- Patients and their family members refused to be enrolled;
- patients were unable to communicate because of language disorders such as dementia and hearing impairment;
- patients were admitted to ICU 48 hours before operation;
- preoperative diagnosis of ARDS, aspiration pneumonia, pulmonary embolism or pulmonary edema or other acute respiratory diseases;
- mechanical ventilation within one week before operation;
- death or discharge within 24 hours after operation;
- second operation due to postoperative complications
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Patients with pulmonary complications following abdominal surgery
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Patients without pulmonary complications following abdominal surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence and risk factors of pulmonary complications
Time Frame: 1 week after surgery
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1 week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ventilation duration,length of stay in ICU and Hospital Stay and death
Time Frame: within the 30 days after surgery
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within the 30 days after surgery
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incidence of Major Extrapulmonary Complications
Time Frame: within the 30 days after surgery
|
within the 30 days after surgery
|
|
Biomarkers
Time Frame: 1 week after surgery
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1 week after surgery
|
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incidence and risk factors of various specific pulmonary complications
Time Frame: 1 week after surgery
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1 week after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Anticipated)
November 1, 2021
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
November 10, 2021
First Posted (Actual)
November 23, 2021
Study Record Updates
Last Update Posted (Actual)
November 23, 2021
Last Update Submitted That Met QC Criteria
November 10, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PPC202108
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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