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

NCT ID: NCT06354569

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative Respiratory Adverse Events

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanyu Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ting Xu

Role: STUDY_DIRECTOR

Sichuan provincial Peopel'Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sichuan provincial Peopel'Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yanyu Liu

Role: CONTACT

+8613438348895

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yanyu Liu

Role: primary

+8613438348895

Ting Xu

Role: backup

+8317708130267

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022.232

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.