Ventilator LungNCT05059366
Manual Ventilation Efficacy With MVG Device
A study testing Manual Ventilation Grip Device and 2VE in people with Ventilator Lung, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- Manual Ventilation Grip Device and 2VE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Current medical students, Post Graduate Year 1 (PGY1) residents or residents from other specialties with no prior experience in hand mask ventilation techniques or anesthesiology residents and attendings with at least 2 or more years of clinical experience
Who cannot join
- Refusal to participate in the study.
- Medical students with prior experience in hand mask ventilation techniques (i.e. experiences in previous careers such as nursing or Emergency Medical Technician (EMT) professions)
- Any physical inability to adequately perform ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Manual Ventilation Efficacy With Ventilation Grip Device: A Manikin Study
The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device).
- Conditions
- Ventilator Lung
- Being tested
- Manual Ventilation Grip Device, 2VE
- Keywords
- Manual Ventilation Grip Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Ventilation Grip DeviceDevice
Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.
2VEOther
the standard 2VE technique for ventilation
| Study group | Role | What they receive |
|---|---|---|
| Expert participants randomized to MVG followed by 2VE | Experimental | Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the Manual ventilation grip device (MVG) first followed by the standard 2VE technique alone. Receives: Device: Manual Ventilation Grip Device; Other: 2VE |
| Expert participants randomized to 2VE followed by MVG | Experimental | Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG). Receives: Device: Manual Ventilation Grip Device; Other: 2VE |
| Novice participants randomized to MVG followed by 2VE | Experimental | Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone Receives: Device: Manual Ventilation Grip Device; Other: 2VE |
| Novice participants randomized to 2VE followed by MVG | Experimental | Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG) Receives: Device: Manual Ventilation Grip Device; Other: 2VE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume
As measured using the ventilator machine in milliliters
Measured: Day 1
Secondary outcomes (2)
Fatigue as Measured by NASA-TLX Questionnaire
NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand.
Measured: Day 1
Fatigue as Measured by SOFI Questionnaire
Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start11 Aug 2021
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventilator LungStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a repeated-measures cross over design.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alecia Stein, University of Miami
- Investigators
- Alecia Stein, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059366
- Sponsor's protocol ID
- 20200039
- Status last verified
- Jul 2022
- First submitted
- 3 Sep 2021
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Manual Ventilation Efficacy With Ventilation Grip Device: A Manikin Study
- ClinicalTrials.gov ID
- NCT05059366
- Acronym / sponsor ID
- 20200039
- Conditions
- Ventilator Lung
- Keywords
- Manual Ventilation Grip Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is a repeated-measures cross over design.
| Arm | Type | Receives |
|---|---|---|
| Expert participants randomized to MVG followed by 2VE | Experimental | Device: Manual Ventilation Grip Device, Other: 2VEExpert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the Manual ventilation grip device (MVG) first followed by the standard 2VE technique alone. |
| Expert participants randomized to 2VE followed by MVG | Experimental | Device: Manual Ventilation Grip Device, Other: 2VEExpert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG). |
| Novice participants randomized to MVG followed by 2VE | Experimental | Device: Manual Ventilation Grip Device, Other: 2VENovice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone |
| Novice participants randomized to 2VE followed by MVG | Experimental | Device: Manual Ventilation Grip Device, Other: 2VENovice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Current medical students, Post Graduate Year 1 (PGY1) residents or residents from other specialties with no prior experience in hand mask ventilation techniques or anesthesiology residents and attendings with at least 2 or more years of clinical experience
Key exclusion criteria (3 listed)
- Refusal to participate in the study.
- Medical students with prior experience in hand mask ventilation techniques (i.e. experiences in previous careers such as nursing or Emergency Medical Technician (EMT) professions)
- Any physical inability to adequately perform ventilation
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 |
|---|---|---|
| Manual Ventilation Grip DeviceManual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation. | Device | Expert participants randomized to 2VE followed by MVG, Expert participants randomized to MVG followed by 2VE, Novice participants randomized to 2VE followed by MVG, Novice participants randomized to MVG followed by 2VE |
| 2VEthe standard 2VE technique for ventilation | Other | Expert participants randomized to 2VE followed by MVG, Expert participants randomized to MVG followed by 2VE, Novice participants randomized to 2VE followed by MVG, Novice participants randomized to MVG followed by 2VE |
Primary outcome
Tidal Volume
Time frame: Day 1
As measured using the ventilator machine in milliliters
2 secondary outcomes
Fatigue as Measured by NASA-TLX Questionnaire
Time frame: Day 1
Fatigue as Measured by SOFI Questionnaire
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alecia Stein principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Ventilation Grip Device and 2VE in people with Ventilator Lung, run by University of Miami at 1 site in United States.
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 3 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 18 Jul 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Day 1). 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 18 Jul 2022.