Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 3:42 PM
Study NCT ID:
NCT03119935
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amflow-device Can Help Proper Ambu-bag Ventilation
Sponsor:
Konkuk University Medical Center
Organization:
Study Overview
Official Title:
Evaluation of an Amflow-device Assist Ambu-bagging to Improve Accuracy of Tidal Volumes Delivered.
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: