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Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02259569
Enrollment
34
Registered
2014-10-08
Start date
2014-10-31
Completion date
2015-02-28
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Urologic Surgeries

Keywords

Gastric insufflation, I-gel, Peak airway pressure, Pressure-controlled ventilation, Volume-Controlled Ventilation, pediatric patient

Brief 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

Interventions

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No

Inclusion criteria

① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.

Exclusion criteria

* parent refusal * clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration

Design outcomes

Primary

MeasureTime frame
Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.1 min after I-gel insertion

Secondary

MeasureTime frameDescription
oropharyngeal leak pressure1 min after caudal block
FOB grade1 min after I-gel insertiongrade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible
peak airway pressure1 min after I-gel insertion

Other

MeasureTime frameDescription
dynamic compliance1 min after end of surgery
typical gurgle or whoosh sound1 min after caudal blockgastric insufflation determined by continuous epigastric auscultation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026