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Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

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ClinicalTrials.gov Identifier: NCT02751047
Recruitment Status : Unknown
Verified June 2016 by Jin-Tae Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : April 26, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:
The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.

Condition or disease Intervention/treatment Phase
Ventilation Other: manual ventilation Other: Pressure controlled mechanical ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children
Study Start Date : May 2016
Estimated Primary Completion Date : October 2017

Arm Intervention/treatment
Placebo Comparator: Manual ventilation
During anesthetic induction, facemask ventilation is performed by manual bagging, after setting adjustable pressure limiting (APL) valve at 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation.
Other: manual ventilation
Facemask ventilation is performed by manual bagging with reservoir bag.

Active Comparator: Pressure controlled mechanical ventilation
During anesthetic induction, facemask ventilation is performed with mechanical ventilator by pressure controlled mode, with inspiratory pressure of 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation.
Other: Pressure controlled mechanical ventilation
Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.




Primary Outcome Measures :
  1. Incidence of gastric insufflation [ Time Frame: During facemask ventilation (90 seconds) ]

Secondary Outcome Measures :
  1. The number of patients with adequate tidal volume [ Time Frame: During facemask ventilation (90 seconds) ]
    Tidal volume of 6 - 10 ml/kg



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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with American Society of Anesthesiologist (ASA) physical status 1, 2
  • Children with normal body mass index

Exclusion Criteria:

  • Difficult airway management
  • pulmonary disease
  • upper respiratory infection
  • risk of pulmonary aspiration
  • intestinal obstruction or abdominal distension
  • stroke history or moyamoya disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751047


Contacts
Contact: Jin-Tae Kim, PhD 82-2-2072-3592 jintae73@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin-Tae Kim, MD. PhD.    82-2-2072-3664    kimjintae73@dreamwiz.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin-Tae Kim, PhD Seoul National University Hospital

Responsible Party: Jin-Tae Kim, Associated professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02751047     History of Changes
Other Study ID Numbers: H1602-094-741
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided