Identifying risk factors for respiratory issues in children during surgery

Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children

This study is trying to find out what factors might put children at risk for breathing problems during surgery so doctors can better protect them.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 1 Month to 12 Years
• Sex: All
• Sponsor: Sichuan Provincial People's Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06354569 on ClinicalTrials.gov

What this trial studies

This study aims to explore the risk factors associated with perioperative respiratory adverse events in children undergoing elective surgery under general anesthesia. It involves collecting data from 600 children, including demographic information, medical history, and details about the surgical procedure and anesthesia management. The researchers will utilize advanced statistical methods, such as the LASSO algorithm and gradient boosting machine, to develop a predictive model for identifying children at risk of respiratory complications during surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 month to 12 years who are classified as ASA Class I or II and scheduled for surgery under general anesthesia.

Not a fit: Patients with severe chronic respiratory, cardiovascular, or other significant health issues, as well as those with active respiratory infections on the day of surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety of pediatric surgeries by improving risk prediction for respiratory adverse events.

How similar studies have performed: While similar studies have explored risk factors for respiratory complications, this specific predictive modeling approach in a pediatric population is relatively novel.

Eligibility criteria

Inclusion Criteria:

* （1）Children aged 1 month to 12 years, （2） ASA Class I or II, （3）scheduled for surgery under general anesthesia

Exclusion Criteria:

-（1）Children and guardians declined to participate in the study (2) children with severe chronic respiratory, cardiovascular, central nervous system, liver and kidney diseases; (3) on the day of operation, the patients had active URTI and pulmonary infection, such as severe nasal obstruction, large amount of airway secretion, severe cough, fever (body temperature \> 37.5 ° C) , in addition to the above symptoms, signs of pulmonary consolidation and/or wet Rales, or peripheral white blood cells \> 10 × 109/L or \< 4 × 109/L with or without left shift of the nucleus, and chest X-ray showed new patchy, patchy infiltrative shadows or interstitial changes.

(4) the child had severe anaphylaxis to narcotic drugs

Where this trial is running

Chengdu, Sichuan

• Sichuan provincial Peopel'Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yanyu Liu

Conditions Perioperative Respiratory Adverse Events; respiratory adverse events, risk prediction, children