Ventilator Lung
Conditions
Keywords
Manual Ventilation Grip Device
Brief summary
The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device).
Interventions
DEVICEManual Ventilation Grip Device
Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.
OTHER2VE
the standard 2VE technique for ventilation
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study is a repeated-measures cross over design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
1. Refusal to participate in the study. 2. 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) 3. Any physical inability to adequately perform ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tidal Volume | Day 1 | As measured using the ventilator machine in milliliters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue as Measured by NASA-TLX Questionnaire | Day 1 | NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand. |
| Fatigue as Measured by SOFI Questionnaire | Day 1 | Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Novices Group 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. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Experts Group | Novices Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Tidal Volume
As measured using the ventilator machine in milliliters
Time frame: Day 1
Population: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experts Group | Tidal Volume | MVG technique | 502.030 mL | Standard Error 11.372 |
| Experts Group | Tidal Volume | 2VE technique | 478.889 mL | Standard Error 12.462 |
| Novices Group | Tidal Volume | MVG technique | 492.508 mL | Standard Error 10.22 |
| Novices Group | Tidal Volume | 2VE technique | 481.533 mL | Standard Error 11.2 |
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.
Time frame: Day 1
Population: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experts Group | Fatigue as Measured by NASA-TLX Questionnaire | MVG technique | 33.92 score on a scale | Standard Error 5.23 |
| Experts Group | Fatigue as Measured by NASA-TLX Questionnaire | 2VE technique | 42.54 score on a scale | Standard Error 5.24 |
| Novices Group | Fatigue as Measured by NASA-TLX Questionnaire | MVG technique | 53.69 score on a scale | Standard Error 6.74 |
| Novices Group | Fatigue as Measured by NASA-TLX Questionnaire | 2VE technique | 63.69 score on a scale | Standard Error 6.28 |
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
Time frame: Day 1
Population: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experts Group | Fatigue as Measured by SOFI Questionnaire | 2VE technique | 16.38 score on a scale | Standard Error 3.13 |
| Experts Group | Fatigue as Measured by SOFI Questionnaire | MVG technique | 13.08 score on a scale | Standard Error 3.32 |
| Novices Group | Fatigue as Measured by SOFI Questionnaire | MVG technique | 17.13 score on a scale | Standard Error 2.97 |
| Novices Group | Fatigue as Measured by SOFI Questionnaire | 2VE technique | 23.28 score on a scale | Standard Error 2.74 |