PneumoniaNCT03359044
Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study
An observational study of Pneumonia and Atelectasis, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Atelectasis, Cough
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 30 Nov 2020
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: (1)Age 4-10Years;(2)ASAⅠ～Ⅱ;(3)Plan to accept fiberoptic bronchoscopy treatment;(4) lives in the city where the research unit is located;(5)signed informed consent
Who may be able to join
- Age 4-10 years
- American society of anesthesiologists(ASA) gradeⅠ～Ⅱ
- Plan to accept fiberoptic bronchoscopy treatment
- lives in the city where the research unit is located
- signed informed consent
Who cannot join
- preterm infants less than 28 weeks of gestational age or preoperative screening found that development, cognitive or behavioral abnormalities
- known congenital malformations may have a potential impact on the development of children's neuropsychological function
- known to have central nervous system disorders or meet the diagnostic criteria of Diagnostic and Statistical Manual(DSM) mental illness
- children with contraindications to intravenous general anesthesia
About this study
Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Several early retrospective studies suggest that, in addition to the possible increase in costs, general anesthesia in intraoperative complications, postoperative recovery and other aspects did not bring significant improvement. But clinically we observed that children under sedation often can not cooperate, they often shows anxiety,restless,crying,and so on, under these situation, some restraint measures may be used, which may have an impact on the child's neuropsychological development. Therefore ,we design this study ,aiming to compare the influence between sedation and general anesthesia (GA) on children 's neuropsychological development.
- Conditions
- Pneumonia, Atelectasis, Cough
- Keywords
- Fiberoptic bronchoscopy, Neuropsychological Development, general anesthesia
- Medical subject headings
- Pneumonia, Pulmonary Atelectasis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sedation + topical anesthesia | midazolam 0.1～0.2 mg/kg for sedation, 2%lidocaine for topical anesthesia | |
| General anesthesia+ topical anesthesia | propofol 4～5mg/kg、Remifentanil2～3μg/kg for induction ,insert Laryngeal Mask Airway(LMA) , 2%lidocaine for topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of abnormal behavior in both groups
Using the Achenbach Child Behavior Checklist(CBCL)for Parents.The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.
Measured: Three years after operation
Secondary outcomes (1)
Full Scale Intelligence Quotient (FSIQ) Score of the Wechsler Intelligence Scale for Children (WISC)-IV
The WISC-IV is designed for children 6 years 0 months to 16 years 11 months. This study used the Full Scale IQ, which ranges from 45 to 155 with a mean of 100 and standard deviation of 15. Higher scores indicate stronger cognitive function. Scores between 90 and 110 are considered to be within the range of average IQ
Measured: Three years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359044
- Sponsor's protocol ID
- SAHoWMU-CR2017-03-208
- Status last verified
- Oct 2017
- First submitted
- 27 Nov 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study
- ClinicalTrials.gov ID
- NCT03359044
- Acronym / sponsor ID
- SAHoWMU-CR2017-03-208
- Conditions
- Pneumonia, Atelectasis, Cough
- Keywords
- Fiberoptic bronchoscopy, Neuropsychological Development, general anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 2 Dec 2017 (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.
Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Several early retrospective studies suggest that, in addition to the possible increase in costs, general anesthesia in intraoperative complications, postoperative recovery and other aspects did not bring significant improvement. But clinically we observed that children under sedation often can not cooperate, they often shows anxiety,restless,crying,and so on, under these situation, some restraint measures may be used, which may have an impact on the child's neuropsychological development. Therefore ,we design this study ,aiming to compare the influence between sedation and general anesthesia (GA) on children 's neuropsychological development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation + topical anesthesia | – | –midazolam 0.1～0.2 mg/kg for sedation, 2%lidocaine for topical anesthesia |
| General anesthesia+ topical anesthesia | – | –propofol 4～5mg/kg、Remifentanil2～3μg/kg for induction ,insert Laryngeal Mask Airway(LMA) , 2%lidocaine for topical anesthesia |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- (1)Age 4-10Years;(2)ASAⅠ～Ⅱ;(3)Plan to accept fiberoptic bronchoscopy treatment;(4) lives in the city where the research unit is located;(5)signed informed consent
Key inclusion criteria (5 listed)
- Age 4-10 years
- American society of anesthesiologists(ASA) gradeⅠ～Ⅱ
- Plan to accept fiberoptic bronchoscopy treatment
- lives in the city where the research unit is located
- signed informed consent
Key exclusion criteria (4 listed)
- preterm infants less than 28 weeks of gestational age or preoperative screening found that development, cognitive or behavioral abnormalities
- known congenital malformations may have a potential impact on the development of children's neuropsychological function
- known to have central nervous system disorders or meet the diagnostic criteria of Diagnostic and Statistical Manual(DSM) mental illness
- children with contraindications to intravenous general anesthesia
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 detection rate of abnormal behavior in both groups
Time frame: Three years after operation
Using the Achenbach Child Behavior Checklist(CBCL)for Parents.The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.
1 secondary outcome
Full Scale Intelligence Quotient (FSIQ) Score of the Wechsler Intelligence Scale for Children (WISC)-IV
Time frame: Three years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Atelectasis, run by Second Affiliated Hospital of Wenzhou Medical University.
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 5 inclusion and 4 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of abnormal behavior in both groups (time frame: Three years after operation). 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 4 Jan 2018.