Pediatric Urologic SurgeriesNCT02259569
Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient
A study of Pediatric Urologic Surgeries, run by Yonsei University.
Trial summary
The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Pediatric Urologic Surgeries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Feb 2015
- Phase
- Interventional
- 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.
Who cannot join
- parent refusal
- clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration
About this study
The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient
- Conditions
- Pediatric Urologic Surgeries
- Being tested
- Pressure-controlled ventilation, Volume-controlled ventilation
- Keywords
- Gastric insufflation, I-gel, Peak airway pressure, Pressure-controlled ventilation, Volume-Controlled Ventilation, pediatric patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure-controlled ventilationOther
Volume-controlled ventilationOther
| Study group | Role | What they receive |
|---|---|---|
| PCV group | Experimental | After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode. Receives: Other: Pressure-controlled ventilation |
| VCV group | Active comparator | After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode. Receives: Other: Volume-controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.
Measured: 1 min after I-gel insertion
Secondary outcomes (3)
oropharyngeal leak pressure
Measured: 1 min after caudal block
FOB grade
grade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible
Measured: 1 min after I-gel insertion
peak airway pressure
Measured: 1 min after I-gel insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Urologic SurgeriesStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259569
- Sponsor's protocol ID
- 4-2014-0594
- Status last verified
- Apr 2015
- First submitted
- 22 Sep 2014
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient
- ClinicalTrials.gov ID
- NCT02259569
- Acronym / sponsor ID
- 4-2014-0594
- Conditions
- Pediatric Urologic Surgeries
- Keywords
- Gastric insufflation, I-gel, Peak airway pressure, Pressure-controlled ventilation, Volume-Controlled Ventilation, pediatric patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Oct 2014 (estimated)
- 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.
The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV group | Experimental | Other: Pressure-controlled ventilationAfter insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode. |
| VCV group | Active comparator | Other: Volume-controlled ventilationAfter insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.
Key exclusion criteria (2 listed)
- parent refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure-controlled ventilation | Other | PCV group |
| Volume-controlled ventilation | Other | VCV group |
Primary outcome
Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.
Time frame: 1 min after I-gel insertion
3 secondary outcomes
oropharyngeal leak pressure
Time frame: 1 min after caudal block
FOB grade
Time frame: 1 min after I-gel insertion
peak airway pressure
Time frame: 1 min after I-gel insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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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?
A study of Pediatric Urologic Surgeries, run by Yonsei 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 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: finished, as of the sponsor's last update on 24 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography. (time frame: 1 min after I-gel insertion). 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 24 Apr 2015.