NCT07157111

Brief 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. The main question it aims to answer is the appropriate timing of elective non-cardiac surgery in the post-COVID-19 era.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

August 28, 2025

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    The postoperative complications including hemorrhage, infection, gastrointestinal complications, respiratory adverse events (RAE), and recurrence of the primary disease.

    7days

Secondary Outcomes (5)

  • Intraoperative RAE

    1day

  • Emergence RAE

    1day

  • PACU stay

    1hour

  • Total hospital length of stay

    10days

  • Postoperative length of stay

    7days

Study Arms (4)

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

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Postoperative ComplicationsCOVID-19

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • aihua Du, Dr.

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

September 1, 2025

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations