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Comparison of Peak Airway Pressure and Gastric Insufflation in Manual Ventilation and Pressure-controlled Ventilation With Facemask During Anesthesia Induction in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02224196
Enrollment
48
Registered
2014-08-25
Start date
2014-08-13
Completion date
2015-01-30
Last updated
2017-01-25

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

Conditions

Elective Urologic Surgeries

Keywords

manual ventilation, pressure-controlled ventilation, peak airway pressure, antral area

Brief summary

Comparison of peak airway pressure and gastric insufflation in manual ventilation and pressure-controlled ventilation with facemask during anesthesia induction in children.

Interventions

Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.

Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
Yes

Inclusion criteria

1. ASA physical status with I or II 2. Those parents who signed with informed consents. 3. Children who are scheduled for elective urologic surgery (aged 6 month to 7 year)

Exclusion criteria

1. Risk of aspiration 2. Oropharyngeal or facial anomaly 3. history of abdominal (stomach) surgery

Design outcomes

Primary

MeasureTime frameDescription
peak airway pressure3 minutesThe primary outcome is the difference of peak airway pressure produced by manual ventilation group and pressure-controlled ventilation group during induction of anesthesia.

Secondary

MeasureTime frameDescription
antral area of stomach3 minutesAll patients' antral area of stomach will be calculated by ultrasound after 3 minutes-facemask ventilation to estimate the quantity of gas insufflation.

Countries

South Korea

Outcome results

None listed

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