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Oxygenation Via Frova Bougie and Ambu Bag

Comparison of Volumes of Air Delivered Through a Frova Intubation Bougie by a Maximal Bimanual Compression Versus a Normal Bimanual Compression of an Adult Ambu® Bag

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02786355
Enrollment
35
Registered
2016-06-01
Start date
2016-02-29
Completion date
2016-03-31
Last updated
2018-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed or Difficult Intubation

Brief summary

We will conduct this study to show that it is possible to deliver air through a Frova bougie and an Ambu® bag.

Detailed description

Participants will be invited to squeeze an Ambu® bag connected to a Frova bougie, and we will measure the volume of air delivered and peak pressure generated.

Interventions

OTHERFrova bougie

Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* staff, fellows and resident anesthesiologists

Exclusion criteria

* injury to hand

Design outcomes

Primary

MeasureTime frameDescription
Tidal Volume (ml)15 minutesvolume of air delivered via Frova bougie (milliliters)

Countries

Canada

Participant flow

Pre-assignment details

This study design involves a cross-over of participants (i.e., participants are randomly assigned to one of the four groups after which they crossover to the other 3).

Participants by arm

ArmCount
Maximum and Normal Effort Using Long and Short Frova Bougies
In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order. Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered.
35
Total35

Baseline characteristics

CharacteristicMaximum and Normal Effort Using Long and Short Frova Bougies
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
35 Participants
Region of Enrollment
Canada
35 Participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 35
serious
Total, serious adverse events
0 / 35

Outcome results

Primary

Tidal Volume (ml)

volume of air delivered via Frova bougie (milliliters)

Time frame: 15 minutes

ArmMeasureValue (MEAN)Dispersion
Maximum Effort: LongTidal Volume (ml)954.8 tidal volume (ml)Standard Deviation 120.7
Normal Effort: LongTidal Volume (ml)554.4 tidal volume (ml)Standard Deviation 131.3
Maximum Effort: ShortTidal Volume (ml)893.5 tidal volume (ml)Standard Deviation 171.6
Normal Effort: ShortTidal Volume (ml)542.9 tidal volume (ml)Standard Deviation 132.9

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026