Postoperative Pulmonary ComplicationsNCT04967651
Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications
An observational study of Postoperative Pulmonary Complications, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pulmonary Complications
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2021to Dec 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older who planned elective cardiac surgery under general anesthesia
Who may be able to join
- Adult patients aged 18 years or older;
- Elective cardiac surgery under general anesthesia
Who cannot join
- Patients and their family members refused to be enrolled;
- Patients unable to communicate due to language barriers such as dementia;
- Patients admitted to ICU 24h before surgery;
- Estimated duration of surgery less than 2 hours;
- Patients died or discharged within 24 hours after surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan
Qingping Wu, wqp1968@163.com
About this study
Official title: Analysis of Risk Factors and Establishment and Application of a Clinical Early Warning Model for Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.
- Conditions
- Postoperative Pulmonary Complications
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 |
|---|---|---|
| Patients with pulmonary complications following cardiac surgery | Not described | |
| Patients without pulmonary complications following cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of postoperative pulmonary complications
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start23 Aug 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Central Hospital, Shanxi Cardiovascular Hospital, Qinghai People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967651
- Sponsor's protocol ID
- PPC202106
- Status last verified
- Oct 2021
- First submitted
- 15 Jul 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors and Establishment and Application of a Clinical Early Warning Model for Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04967651
- Acronym / sponsor ID
- PPC202106
- Conditions
- Postoperative Pulmonary Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Central Hospital, Shanxi Cardiovascular Hospital, Qinghai People's Hospital
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Jul 2021 (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.
The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary complications following cardiac surgery | – | – |
| Patients without pulmonary complications following cardiac surgery | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who planned elective cardiac surgery under general anesthesia
Key inclusion criteria (2 listed)
- Adult patients aged 18 years or older;
- Elective cardiac surgery under general anesthesia
Key exclusion criteria (5 listed)
- Patients and their family members refused to be enrolled;
- Patients unable to communicate due to language barriers such as dementia;
- Patients admitted to ICU 24h before surgery;
- Estimated duration of surgery less than 2 hours;
- Patients died or discharged within 24 hours after surgery
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 occurrence of postoperative pulmonary complications
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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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.
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 Postoperative Pulmonary Complications, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 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 3 Nov 2021. 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 Qingping Wu (13971605283, wqp1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of postoperative pulmonary complications (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.