Amflow-device Can Help Proper Ambu-bag Ventilation

Evaluation of an Amflow-device Assist Ambu-bagging to Improve Accuracy of Tidal Volumes Delivered.

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

Study Overview

• Status: Completed
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Device: Amflow; Device: Ambu bag

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Department of Emergency Medicine, Konkuk University Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• A participants who does not agree attend this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume	We compared mean tidal volume delivered to manikins between two techniques	6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation Rate	We compared mean ventilation rate between two techniques	6 minutes

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Sang O Park, Dr, Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: ambu bag, ventilation, tidal volume
• Other Study ID Numbers: Amflow

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No