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

Perioperative Respiratory Adverse Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354569
• Other study ID #: 2022.232
• Status: Recruiting
• Start date: December 31, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Sichuan Provincial People's Hospital
• Contact: Yanyu Liu
• Phone: +8613438348895
• Email: 43197113[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children

Description:

600 children undergoing elective surgery under general anesthesia were selected. Age, sex, weight, height, allergy history, past history, snoring, passive smoking, abnormal laboratory examination and chest X-ray before operation, upper respiratory tract infection 14 days before operation, Operation Site, working years of anesthesiologist, anesthesia method, Operation Duration, anesthesia duration, perioperative vital signs and respiratory adverse events were collected. The risk prediction model of perioperative respiratory adverse events in children was established by using LASSO (least absolute shrinkage and selection operator) algorithm and gradient boosting machine (GBM) algorithm to screen the relevant data collected during routine diagnosis and treatment, such as demographic characteristics, physical conditions, airway sensitivity, environmental sensitivity and anesthesia management

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Respiratory Adverse Events

Locations

Country	Name	City	State
China	Sichuan provincial Peopel'Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of perioperative respiratory adverse events	Collection of respiratory adverse events including laryngeal spasm, Bronchospasm, decreased oxygen saturation, and increased secretions	perioperative