Status unknownNCT03881033Updated Mar 19, 2019

Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

An interventional study of Peep 5cmH2O and Peak inspiratory pressure in Ventilator Lung and Ultrasound, sponsored by Ajou University School of Medicine. Status unknown. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2019-03-19.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 1 Year to 5 Years
Sex: All

Study summary

The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.

The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.

Conditions studied

Ventilator Lung
Ultrasound

In context

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.

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Who can participate

Ages eligible: 1 Year to 5 Years
Sexes eligible: All
Accepts healthy volunteers: No

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Inclusion criteria

The ASA class I,II and 1-5 years pediatric patients need general anesthesia

Exclusion criteria

Exclusion Criteria:

Oropharyngeal or facial pathology accompanied
Obese (BMI > 30 kg/m2)
GI tract obstruction

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 70 participants (estimated)

Study arms

Placebo comparator
P12
Other: Peak inspiratory pressure
Active comparator
P7+5
Other: Peep 5cmH2O

Interventions

OtherPeep 5cmH2O
Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.
Also known as: Peak inspiratory pressure
OtherPeak inspiratory pressure
Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.

What researchers measure

Primary outcomes

The degree of atelectasis
After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.
Time frame: 1min after ventilator-on

Secondary outcomes

The incidence of gastric insufflation
Time frame: During face mask ventilation

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2019; primary completion for Sep 2019, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 12, 2019
First posted: Mar 19, 2019
StartEst.: Apr 1, 2019
Primary completionEst.: Sep 30, 2019
CompletionEst.: Nov 30, 2019
Last update: Mar 19, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03881033
Lead sponsor: Ajou University School of Medicine
Responsible party: Jiyoung Yoo (assistant professor, Ajou University School of Medicine) — Principal investigator
First posted: Mar 19, 2019
Start date: Apr 1, 2019 (estimated)
Primary completion: Sep 30, 2019 (estimated)
Completion: Nov 30, 2019 (estimated)
Last update: Mar 19, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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