Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Ventilator Lung Ultrasound Other: Peep 5cmH2O Other: Peak inspiratory pressure Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: P12 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.

Active Comparator: P7+5 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




Primary Outcome Measures :
  1. The degree of atelectasis [ Time Frame: 1min after ventilator-on ]
    After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.


Secondary Outcome Measures :
  1. The incidence of gastric insufflation [ Time Frame: During face mask ventilation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Jiyoung Yoo, assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03881033     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-18-192
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No