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

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ClinicalTrials.gov Identifier: NCT03881033
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jiyoung Yoo, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
The degree of atelectasis [ Time Frame: 1min after ventilator-on ]
After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
The incidence of gastric insufflation [ Time Frame: During face mask ventilation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography
Official Title  ICMJE Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Ventilator Lung
  • Ultrasound
Intervention  ICMJE
  • Other: Peep 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.
    Other Name: Peak inspiratory pressure
  • Other: Peak 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.
Study Arms  ICMJE
  • Placebo Comparator: P12
    Intervention: Other: Peak inspiratory pressure
  • Active Comparator: P7+5
    Intervention: Other: Peep 5cmH2O
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Oropharyngeal or facial pathology accompanied
  • Obese (BMI > 30 kg/m2)
  • GI tract obstruction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881033
Other Study ID Numbers  ICMJE AJIRB-MED-OBS-18-192
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiyoung Yoo, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ajou University School of Medicine
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP