Postoperative Pulmonary ComplicationsNCT05701449
Prevention and Treatment of Perioperative Lung Injury in Elderly Patients
An observational study of Postoperative Pulmonary Complications and Elderly Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This study aims to verify the prediction model of postoperative pulmonary complications by collecting clinical information on elderly patients. In addition, the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model was compared. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications, Elderly Patients
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2023
- 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 65 years and older
- All sexes
- Older adult
Study population: Patients aged 65 years or older
Who may be able to join
- Age 65 years or older
- receiving invasive ventilation during general anesthesia for surgery
Who cannot join
- preoperative mechanical ventilation
- procedures related to a previous surgical complication
- a second operation after surgery within one week
- organ transplantation
- discharged within 24 hours after surgery
About this study
This study aims to verify the prediction model of postoperative pulmonary complications by collecting clinical information on elderly patients. In addition, the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model was compared.
Read the detailed description
More than 300 million major operations are performed worldwide each year, and older patients account for about a third of elective operations. Compared with young people, the elderly are more prone to postoperative complications due to age-related degeneration of the physiological functions of various organs and tissues. Postoperative pulmonary complications, including pneumonia, atelectasis, and respiratory failure, are common. Even mild pulmonary complications can lead to the prolonged hospital stay and increased postoperative mortality.
Although there have been many studies on postoperative lung complications, there have been few studies on elderly patients. In our country, the real incidence data of elderly patients after a perioperative period of pulmonary complications, the lack of effective prevention, intervention measures, and targeted prevention and treatment technology, these reasons lead to the clinical diagnosis and treatment of elderly patients after a perioperative period of pulmonary complications are very difficult. Therefore, the research team intends to verify the established prediction model of postoperative pulmonary complications and compare the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model.
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 applying a prediction model for postoperative pulmonary complications | Not described | |
| Patients non-applying a prediction model for postoperative pulmonary complications | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Measured: within one week after surgery
Secondary outcomes (2)
Length of postoperative hospital stay
Measured: 6 weeks after surgery
Postoperative Death
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Taihe Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Guangxi Medical University, Qinghai People's Hospital, Shanxi Cardiovascular Hospital, Wuhan No.1 Hospital, Shiyan City Renmin Hospital, Dongfeng General Hospital of Chinese Medicine, Xiangyang Central Hospital, Xiangyang No.1 People's Hospital, Hubei University of Medicine, Yunxi Renmin Hospital, Yunyang Renmin Hospital, Zhuxi Renmin Hospital, Danjiangkou First Hospital, Shiyan Integrated Traditional and Western Medicine Hospital, Shiyan Traditional Chinese Medicine Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701449
- Sponsor's protocol ID
- PPCS192023
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Perioperative Lung Injury in Elderly Patients
- ClinicalTrials.gov ID
- NCT05701449
- Acronym / sponsor ID
- PPCS192023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Taihe Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Guangxi Medical University, Qinghai People's Hospital, Shanxi Cardiovascular Hospital, Wuhan No.1 Hospital, Shiyan City Renmin Hospital, Dongfeng General Hospital of Chinese Medicine, Xiangyang Central Hospital, Xiangyang No.1 People's Hospital, Hubei University of Medicine, Yunxi Renmin Hospital, Yunyang Renmin Hospital, Zhuxi Renmin Hospital, Danjiangkou First Hospital, Shiyan Integrated Traditional and Western Medicine Hospital, Shiyan Traditional Chinese Medicine Hospital
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jan 2023 (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.
This study aims to verify the prediction model of postoperative pulmonary complications by collecting clinical information on elderly patients. In addition, the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model was compared.
Detailed description
More than 300 million major operations are performed worldwide each year, and older patients account for about a third of elective operations. Compared with young people, the elderly are more prone to postoperative complications due to age-related degeneration of the physiological functions of various organs and tissues. Postoperative pulmonary complications, including pneumonia, atelectasis, and respiratory failure, are common. Even mild pulmonary complications can lead to the prolonged hospital stay and increased postoperative mortality.
Although there have been many studies on postoperative lung complications, there have been few studies on elderly patients. In our country, the real incidence data of elderly patients after a perioperative period of pulmonary complications, the lack of effective prevention, intervention measures, and targeted prevention and treatment technology, these reasons lead to the clinical diagnosis and treatment of elderly patients after a perioperative period of pulmonary complications are very difficult. Therefore, the research team intends to verify the established prediction model of postoperative pulmonary complications and compare the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients applying a prediction model for postoperative pulmonary complications | – | – |
| Patients non-applying a prediction model for postoperative pulmonary complications | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older
Key inclusion criteria (2 listed)
- Age 65 years or older
- receiving invasive ventilation during general anesthesia for surgery
Key exclusion criteria (5 listed)
- preoperative mechanical ventilation
- procedures related to a previous surgical complication
- a second operation after surgery within one week
- organ transplantation
- 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
Postoperative pulmonary complications
Time frame: within one week after surgery
2 secondary outcomes
Length of postoperative hospital stay
Time frame: 6 weeks after surgery
Postoperative Death
Time frame: 6 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Complications and Elderly Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: within one 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 27 Jan 2023.