NCT03881033

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 12, 2019

Last Update Submit

March 18, 2019

Conditions

Ventilator LungUltrasound

Outcome Measures

Primary Outcomes (1)

  • The degree of atelectasis

    After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.

    1min after ventilator-on

Secondary Outcomes (1)

  • The incidence of gastric insufflation

    During face mask ventilation

Study Arms (2)

P12

PLACEBO COMPARATOR
Other: Peak inspiratory pressure

P7+5

ACTIVE COMPARATOR
Other: Peep 5cmH2O

Interventions

Peep 5cmH2OOTHER

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
P7+5
Peak inspiratory pressureOTHER

Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.

P12

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 19, 2019

Study Start

April 1, 2019

Primary Completion

September 30, 2019

Study Completion

November 30, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03