Amflow-device Can Help Proper Ambu-bag Ventilation

Not Applicable

Completed

• Conditions: Ventilation Therapy; Complications
• Interventions: Device: Amflow; Device: Ambu bag

• Registration Number: NCT03119935
• Lead Sponsor: 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

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-19
• Primary Completion: 2017-08-01
• Study Completion: 2017-09-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-17
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• A participants who does not agree attend this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amflow assist ambu bag ventiation	Amflow	Newely developed method (Amflow assist ambu bag ventilation)
Ambu bag ventilation	Ambu bag	Ordinary method (ambu bag ventilation

Primary Outcome Measures

Name	Time	Method
Tidal volume	6 minutes	We compared mean tidal volume delivered to manikins between two techniques

Secondary Outcome Measures

Name	Time	Method
Ventilation Rate	6 minutes	We compared mean ventilation rate between two techniques

Trial Locations

Locations (1)

Department of Emergency Medicine, Konkuk University Medical center; 🇰🇷 Seoul, Korea, Republic of