Amflow-device Can Help Proper Ambu-bag Ventilation

• Sponsor: Konkuk University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03119935
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 13.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Mar 1, 2017
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tidal volume [6 minutes]

   We compared mean tidal volume delivered to manikins between two techniques

Secondary Outcome Measures

1. Ventilation Rate [6 minutes]

   We compared mean ventilation rate between two techniques

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Emergency Medicine, Konkuk University Medical center	Seoul		Korea, Republic of	143-729

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang O, Park, Associate Professor, Konkuk University Medical Center
• ClinicalTrials.gov Identifier: NCT03119935
• Other Study ID Numbers: Amflow
• First Posted: Apr 19, 2017
• Last Update Posted: Dec 19, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sang O, Park, Associate Professor, Konkuk University Medical Center: ambu bag, ventilation, tidal volume

Study Results

No Results Posted as of Dec 19, 2017