URTIURTINCT07157111
Perioperative Outcomes for Children With Preoperative URTI Symptoms After COVID-19 Pandemic
An observational study of URTI and Postoperative Complications, run by aijun xu at 1 site in China.
Trial summary
The goal of this observational study is to investigate the impact of the COVID-19 pandemic on perioperative outcomes in children with preoperative URTI symptoms and to explore whether the COVID-19 pandemic affected the additional surgical risk associated with preoperative URTI symptoms. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- URTI, Postoperative Complications, COVID - 19
- How many people
- 2,392 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 10 Oct 2025
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 0-12 years who underwent elective non-cardiac surgery at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology between January 2015 and December 2024.
Who may be able to join
- Aged 0-12 years
- ASA physical status classification I-III
- Undergoing non-cardiac surgery
- Children presenting with mild URTI symptoms within 2 weeks before surgery
Who cannot join
- Presenting with severe underlying diseases (e.g., congenital heart disease, immunodeficiency)
- Presenting with a single symptom of fever that can be explained by other diseases
- Day surgery
- Children with abnormal preoperative chest X-rays
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Outcomes for Children With Preoperative Upper Respiratory Tract Infection Symptoms in Elective Non-cardiac Surgery After COVID-19 Pandemic at a Large Tertiary Hospital in China: a Retrospective Cohort Study
The goal of this observational study is to investigate the impact of the COVID-19 pandemic on perioperative outcomes in children with preoperative URTI symptoms and to explore whether the COVID-19 pandemic affected the additional surgical risk associated with preoperative URTI symptoms. The main question it aims to answer is the appropriate timing of elective non-cardiac surgery in the post-COVID-19 era.
Read the detailed description
This study aims to investigate the impact of the COVID-19 pandemic on perioperative outcomes in children with preoperative URTI symptoms and to explore whether the COVID-19 pandemic affected the additional surgical risk associated with preoperative URTI symptoms. The findings will provide evidence-based guidance for optimizing surgical timing decisions in the post-COVID-19 era.
- Conditions
- URTI, Postoperative Complications, COVID - 19, Elective Non-cardiac Surgery, Perioperative Respiratory Adverse Events
- Medical subject headings
- Postoperative Complications, COVID-19
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 |
|---|---|---|
| S1 group | children with preoperative upper respiratory tract infections symptoms undergoing elective non-cardiac surgery from January 1, 2015, to December 31, 2019 | |
| C1 group | children without preoperative upper respiratory tract infections undergoing elective non-cardiac surgery from January 1, 2015, to December 31, 2019 | |
| S2 group | children with preoperative upper respiratory tract infections symptoms undergoing elective non-cardiac surgery from January 1, 2020, to December 31, 2024 | |
| C2 group | children without preoperative upper respiratory tract infections symptoms undergoing elective non-cardiac surgery from January 1, 2020, to December 31, 2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
The postoperative complications including hemorrhage, infection, gastrointestinal complications, respiratory adverse events (RAE), and recurrence of the primary disease.
Measured: 7days
Secondary outcomes (5)
Intraoperative RAE
Intraoperative RAE, including hypercapnia, hypoxemia
Measured: 1day
Emergence RAE
Emergence RAE, including hypercapnia, hypoxemia
Measured: 1day
PACU stay
Meeting discharge criteria from PACU
Measured: 1hour
Total hospital length of stay
Total hospital length of stay
Measured: 10days
Postoperative length of stay
Postoperative hospital length of stay
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Sep 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for URTIStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 2,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- aijun xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, aijun xu, Tongji Hospital
- Investigators
- aihua Du, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157111
- Sponsor's protocol ID
- PPOC
- Acronym
- URTI
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protecting research participant privacy
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes for Children With Preoperative Upper Respiratory Tract Infection Symptoms in Elective Non-cardiac Surgery After COVID-19 Pandemic at a Large Tertiary Hospital in China: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07157111
- Acronym / sponsor ID
- URTI / PPOC
- Conditions
- URTI, Postoperative Complications, COVID - 19, Elective Non-cardiac Surgery, Perioperative Respiratory Adverse Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,392 participants (actual)
- Lead sponsor
- aijun xuUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 5 Sep 2025 (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 goal of this observational study is to investigate the impact of the COVID-19 pandemic on perioperative outcomes in children with preoperative URTI symptoms and to explore whether the COVID-19 pandemic affected the additional surgical risk associated with preoperative URTI symptoms. The main question it aims to answer is the appropriate timing of elective non-cardiac surgery in the post-COVID-19 era.
Detailed description
This study aims to investigate the impact of the COVID-19 pandemic on perioperative outcomes in children with preoperative URTI symptoms and to explore whether the COVID-19 pandemic affected the additional surgical risk associated with preoperative URTI symptoms. The findings will provide evidence-based guidance for optimizing surgical timing decisions in the post-COVID-19 era.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S1 group | – | –children with preoperative upper respiratory tract infections symptoms undergoing elective non-cardiac surgery from January 1, 2015, to December 31, 2019 |
| C1 group | – | –children without preoperative upper respiratory tract infections undergoing elective non-cardiac surgery from January 1, 2015, to December 31, 2019 |
| S2 group | – | –children with preoperative upper respiratory tract infections symptoms undergoing elective non-cardiac surgery from January 1, 2020, to December 31, 2024 |
| C2 group | – | –children without preoperative upper respiratory tract infections symptoms undergoing elective non-cardiac surgery from January 1, 2020, to December 31, 2024 |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 0-12 years who underwent elective non-cardiac surgery at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology between January 2015 and December 2024.
Key inclusion criteria (4 listed)
- Aged 0-12 years
- ASA physical status classification I-III
- Undergoing non-cardiac surgery
- Children presenting with mild URTI symptoms within 2 weeks before surgery
Key exclusion criteria (4 listed)
- Presenting with severe underlying diseases (e.g., congenital heart disease, immunodeficiency)
- Presenting with a single symptom of fever that can be explained by other diseases
- Day surgery
- Children with abnormal preoperative chest X-rays
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 complications
Time frame: 7days
The postoperative complications including hemorrhage, infection, gastrointestinal complications, respiratory adverse events (RAE), and recurrence of the primary disease.
5 secondary outcomes
Intraoperative RAE
Time frame: 1day
Emergence RAE
Time frame: 1day
PACU stay
Time frame: 1hour
Total hospital length of stay
Time frame: 10days
Postoperative length of stay
Time frame: 7days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided. Protecting research participant privacy
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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.
aihua Du, Dr. study chair
Tongji Hospital
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 URTI and Postoperative Complications, run by aijun xu 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 complications (time frame: 7days). 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 21 Nov 2025.