Postoperative Pulmonary Complications;Abdominal SurgeryNCT05131009
Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas
An observational study of Postoperative Pulmonary Complications;Abdominal Surgery, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications;Abdominal Surgery
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Nov 2021to Sep 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients aged 18 years or older who planned elective abdominal surgery under general anesthesia
Who may be able to join
- ≥ 18 years old；
- scheduled for elective abdominal surgery under general anesthesia；
- ASAⅠ-Ⅲ
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Qingping Wu, wqp1968@163.com
About this study
Official title: 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.
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 abdominal surgery | Not described | |
| Patients without pulmonary complications following abdominal surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and risk factors of pulmonary complications
Measured: 1 week after surgery
Secondary outcomes (4)
ventilation duration,length of stay in ICU and Hospital Stay and death
Measured: within the 30 days after surgery
incidence of Major Extrapulmonary Complications
Measured: within the 30 days after surgery
Biomarkers
Measured: 1 week after surgery
incidence and risk factors of various specific 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 posted23 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 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 Complications;Abdominal SurgeryStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131009
- Sponsor's protocol ID
- PPC202108
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 23 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Incidence and Risk Factors of Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas
- ClinicalTrials.gov ID
- NCT05131009
- Acronym / sponsor ID
- PPC202108
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Qinghai People's Hospital
- Study start
- Nov 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 23 Nov 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary complications following abdominal surgery | – | – |
| Patients without pulmonary complications following abdominal surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who planned elective abdominal surgery under general anesthesia
Key inclusion criteria (3 listed)
- ≥ 18 years old；
- scheduled for elective abdominal surgery under general anesthesia；
- ASAⅠ-Ⅲ
Key exclusion criteria (7 listed)
- 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；
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
incidence and risk factors of pulmonary complications
Time frame: 1 week after surgery
4 secondary outcomes
ventilation duration,length of stay in ICU and Hospital Stay and death
Time frame: within the 30 days after surgery
incidence of Major Extrapulmonary Complications
Time frame: within the 30 days after surgery
Biomarkers
Time frame: 1 week after surgery
incidence and risk factors of various specific 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 23 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;Abdominal Surgery, 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 3 inclusion and 7 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 23 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, Professor (13971605283, wqp1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and risk factors of 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 23 Nov 2021.