Risk Factors and Risk Grading Prediction of Perioperative... | NCT06354569

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

NCT06354569

Sponsor

Sichuan Provincial People's Hospital

Status

Unknown status

Last Update Posted

Apr 9, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Perioperative Respiratory Adverse Events

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 3, 2024

First Submission Date that Met QC Criteria

Apr 3, 2024

First Posted Date

Apr 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The occurrence of perioperative respiratory adverse events	Collection of respiratory adverse events including laryngeal spasm, Bronchospasm, decreased oxygen saturation, and increased secretions	perioperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

12 Years

Standard Ages

Child

Study Population

Children aged 1 month to 12 years, Asa Class I or II, scheduled for surgery under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanyu Liu	Contact	+8613438348895		43197113@qq.com

Overall Officials

Name	Affiliation	Role
Ting Xu	Sichuan provincial Peopel'Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan provincial Peopel'Hospital	Recruiting	Chengdu	Sichuan		China