NCT06354569

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

April 3, 2024

Last Update Submit

April 3, 2024

Conditions

Keywords

respiratory adverse events, risk prediction, children

Outcome Measures

Primary Outcomes (1)

  • The occurrence of perioperative respiratory adverse events

    Collection of respiratory adverse events including laryngeal spasm, Bronchospasm, decreased oxygen saturation, and increased secretions

    perioperative

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan provincial Peopel'Hospital

Chengdu, Sichuan, China

RECRUITING

Study Officials

  • Ting Xu

    Sichuan provincial Peopel'Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 9, 2024

Study Start

December 31, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations