Ventilation Therapy; ComplicationsNCT03119935
Amflow-device Can Help Proper Ambu-bag Ventilation
A study testing Amflow and Ambu bag in people with Ventilation Therapy; Complications, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- Amflow and Ambu bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A healthy senior medical students who agree attend this study.
Who cannot join
- A participants who does not agree attend this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Emergency Medicine, Konkuk University Medical center
Seoul, 143-729
About this study
Official title: 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
Read the 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.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- Amflow, Ambu bag
- Keywords
- ambu bag, ventilation, tidal volume
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmflowDevice
Amflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag
Ambu bagDevice
Participants ventilated the simulated patients by ambu bag
| Study group | Role | What they receive |
|---|---|---|
| Amflow assist ambu bag ventiation | Experimental | Newely developed method (Amflow assist ambu bag ventilation) Receives: Device: Amflow |
| Ambu bag ventilation | Experimental | Ordinary method (ambu bag ventilation Receives: Device: Ambu bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
We compared mean tidal volume delivered to manikins between two techniques
Measured: 6 minutes
Secondary outcomes (1)
Ventilation Rate
We compared mean ventilation rate between two techniques
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Aug 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang O, Park, Konkuk University Medical Center
- Investigators
- Sang O Park, Dr, Principal investigator, Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119935
- Sponsor's protocol ID
- Amflow
- Status last verified
- Dec 2017
- First submitted
- 14 Apr 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Amflow-device Assist Ambu-bagging to Improve Accuracy of Tidal Volumes Delivered.
- ClinicalTrials.gov ID
- NCT03119935
- Acronym / sponsor ID
- Amflow
- Conditions
- Ventilation Therapy; Complications
- Keywords
- ambu bag, ventilation, tidal volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amflow assist ambu bag ventiation | Experimental | Device: AmflowNewely developed method (Amflow assist ambu bag ventilation) |
| Ambu bag ventilation | Experimental | Device: Ambu bagOrdinary method (ambu bag ventilation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A healthy senior medical students who agree attend this study.
Key exclusion criteria (1 listed)
- A participants who does not agree attend this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmflowAmflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag | Device | Amflow assist ambu bag ventiation |
| Ambu bagParticipants ventilated the simulated patients by ambu bag | Device | Ambu bag ventilation |
Primary outcome
Tidal volume
Time frame: 6 minutes
We compared mean tidal volume delivered to manikins between two techniques
1 secondary outcome
Ventilation Rate
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang O Park, Dr principal investigator
Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amflow and Ambu bag in people with Ventilation Therapy; Complications, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.