Perioperative Respiratory Adverse EventsNCT06354569
Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children
An observational study of Perioperative Respiratory Adverse Events, run by Sichuan Provincial People's Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Perioperative Respiratory Adverse Events
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- Child
Study population: Children aged 1 month to 12 years, Asa Class I or II, scheduled for surgery under general anesthesia
Who may be able to join
- （1）Children aged 1 month to 12 years, （2） ASA Class I or II, （3）scheduled for surgery under general anesthesia
Who cannot join
- -（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.
- the child had severe anaphylaxis to narcotic drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan provincial Peopel'Hospital
Chengdu, Sichuan
Yanyu Liu, +8613438348895, 43197113@qq.com
Ting Xu, +8317708130267
About this study
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
Read the 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
- Conditions
- Perioperative Respiratory Adverse Events
- Keywords
- respiratory adverse events, risk prediction, children
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of perioperative respiratory adverse events
Collection of respiratory adverse events including laryngeal spasm, Bronchospasm, decreased oxygen saturation, and increased secretions
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Respiratory Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanyu Liu, Sichuan Provincial People's Hospital
- Investigators
- Ting Xu, Study director, Sichuan provincial Peopel'Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354569
- Sponsor's protocol ID
- 2022.232
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children
- ClinicalTrials.gov ID
- NCT06354569
- Acronym / sponsor ID
- 2022.232
- Conditions
- Perioperative Respiratory Adverse Events
- Keywords
- respiratory adverse events, risk prediction, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged 1 month to 12 years, Asa Class I or II, scheduled for surgery under general anesthesia
Key inclusion criteria (1 listed)
- （1）Children aged 1 month to 12 years, （2） ASA Class I or II, （3）scheduled for surgery under general anesthesia
Key exclusion criteria (2 listed)
- -（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.
- the child had severe anaphylaxis to narcotic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurrence of perioperative respiratory adverse events
Time frame: perioperative
Collection of respiratory adverse events including laryngeal spasm, Bronchospasm, decreased oxygen saturation, and increased secretions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Xu study director
Sichuan provincial Peopel'Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Respiratory Adverse Events, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanyu Liu (+8613438348895, 43197113@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of perioperative respiratory adverse events (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.