Trial Outcomes & Findings for Manual Ventilation Efficacy With MVG Device (NCT NCT05059366)
NCT ID: NCT05059366
Last Updated: 2022-07-18
Results Overview
As measured using the ventilator machine in milliliters
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Day 1
Results posted on
2022-07-18
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
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
|
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experts Group
n=16 Participants
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.
|
Novices Group
n=16 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
16 Participants
n=16 Participants
|
32 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
15 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
17 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 1Population: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
As measured using the ventilator machine in milliliters
Outcome measures
| Measure |
Experts Group
n=13 Participants
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.
|
Novices Group
n=16 Participants
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.
|
|---|---|---|
|
Tidal Volume
MVG technique
|
502.030 mL
Standard Error 11.372
|
492.508 mL
Standard Error 10.220
|
|
Tidal Volume
2VE technique
|
478.889 mL
Standard Error 12.462
|
481.533 mL
Standard Error 11.200
|
SECONDARY outcome
Timeframe: Day 1Population: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand.
Outcome measures
| Measure |
Experts Group
n=13 Participants
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.
|
Novices Group
n=16 Participants
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.
|
|---|---|---|
|
Fatigue as Measured by NASA-TLX Questionnaire
MVG technique
|
33.92 score on a scale
Standard Error 5.23
|
53.69 score on a scale
Standard Error 6.74
|
|
Fatigue as Measured by NASA-TLX Questionnaire
2VE technique
|
42.54 score on a scale
Standard Error 5.24
|
63.69 score on a scale
Standard Error 6.28
|
SECONDARY outcome
Timeframe: Day 1Population: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue
Outcome measures
| Measure |
Experts Group
n=13 Participants
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.
|
Novices Group
n=16 Participants
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.
|
|---|---|---|
|
Fatigue as Measured by SOFI Questionnaire
MVG technique
|
13.08 score on a scale
Standard Error 3.32
|
17.13 score on a scale
Standard Error 2.97
|
|
Fatigue as Measured by SOFI Questionnaire
2VE technique
|
16.38 score on a scale
Standard Error 3.13
|
23.28 score on a scale
Standard Error 2.74
|
Adverse Events
Manual Ventilation Grip Device (MVG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Technique (2VE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place