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The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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 |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Ventilation Grip Device | Device | Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tidal Volume | As measured using the ventilator machine in milliliters | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Fatigue as Measured by SOFI Questionnaire |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alecia Stein | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Expert Participants Randomized to MVG Followed by 2VE | 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. |
| FG001 | Expert Participants Randomized to 2VE Followed by MVG | 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). |
| FG002 | Novice Participants Randomized to MVG Followed by 2VE | Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone |
| FG003 | Novice Participants Randomized to 2VE Followed by MVG | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experts Group | Anesthesiology residents and attendings with at least 2 or more years of clinical experience conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique. |
| BG001 | Novices Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tidal Volume | As measured using the ventilator machine in milliliters | 3 participants in the experts group were excluded due to unresolvable set-up obstacles | Posted | Mean | Standard Error | mL | Day 1 |
|
1 day
The study is a cross-over design. All participants received both the MVG and 2VE intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Ventilation Grip Device (MVG) | Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alecia Sabartinelli Stein, MD | University of Miami | 305 585 8380 | asabartinelli@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2022 | Jun 10, 2022 | Prot_SAP_000.pdf |
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The study is a repeated-measures cross over design.
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|
| 2VE | Other | the standard 2VE technique for ventilation |
|
Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue
| Day 1 |
Current medical students or residents with no prior experience in hand mask ventilation techniques conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
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| Secondary | 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. | 3 participants in the experts group were excluded due to unresolvable set-up obstacles | Posted | Mean | Standard Error | score on a scale | Day 1 |
|
|
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| Secondary | 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 | 3 participants in the experts group were excluded due to unresolvable set-up obstacles | Posted | Mean | Standard Error | score on a scale | Day 1 |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Standard Technique (2VE) | The standard 2VE technique for ventilation | 0 | 32 | 0 | 32 | 0 | 32 |
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