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Amflow-device Can Help Proper Ambu-bag Ventilation

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. Read our disclaimer for details. Identifier: NCT03119935
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):
Sang O, Park, Konkuk University Medical Center

Brief Summary:
This is a simulation study with a prospective randomized cross-over design. The aim of this study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume compare to ordinary ambu-bag

Condition or disease Intervention/treatment Phase
Ventilation Therapy; Complications Device: Amflow Device: Ambu bag Not Applicable

Detailed Description:

Ambu-bag ventilation is an essential skill to the patients who needed ventilatory support. However, the delivery of appropriate amount of tidal volume by ordinary manual bag ventilation may be difficult. In addition, it require adequate training to rescurer.

We hypothesised that an Amflow assist ambu bag may be helpful to delivery accurate tidal volumes to the patients.

Participants performed bag-valve ventilation to manikin by ordinary technique and Amflow assist technique in our simulation centre. We measured each ventilation rate and ventilation volume in simulated scenario and we compare those between two technique.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an Amflow-device Assist Ambu-bagging to Improve Accuracy of Tidal Volumes Delivered.
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : September 1, 2017

Arm Intervention/treatment
Experimental: Amflow assist ambu bag ventiation
Newely developed method (Amflow assist ambu bag ventilation)
Device: Amflow
Amflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag

Experimental: Ambu bag ventilation
Ordinary method (ambu bag ventilation
Device: Ambu bag
Participants ventilated the simulated patients by ambu bag

Primary Outcome Measures :
  1. Tidal volume [ Time Frame: 6 minutes ]
    We compared mean tidal volume delivered to manikins between two techniques

Secondary Outcome Measures :
  1. Ventilation Rate [ Time Frame: 6 minutes ]
    We compared mean ventilation rate between two techniques

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • A healthy senior medical students who agree attend this study.

Exclusion Criteria:

  • A participants who does not agree attend this study

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 identifier (NCT number): NCT03119935

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Korea, Republic of
Department of Emergency Medicine, Konkuk University Medical center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
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Principal Investigator: Sang O Park, Dr Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
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Responsible Party: Sang O, Park, Associate Professor, Konkuk University Medical Center Identifier: NCT03119935    
Other Study ID Numbers: Amflow
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sang O, Park, Konkuk University Medical Center:
ambu bag, ventilation, tidal volume