CClinicalTrials.gg
CompletedNCT02786355Updated Dec 28, 2018Results posted

Oxygenation Via Frova Bougie and Ambu Bag

An interventional study of Frova bougie in Failed or Difficult Intubation, sponsored by University of British Columbia. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2018-12-28.

Sponsored by University of British Columbia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Failed or Difficult Intubation
03

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • staff, fellows and resident anesthesiologists

Exclusion criteria

Exclusion Criteria:

  • injury to hand
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Other
    Maximum bimanual compression

    Squeeze through Frova bougie with maximum bimanual compression

    Other: Frova bougie

  • Other
    Normal bimanual compression

    Squeeze through Frova bougie with normal bimanual compression

    Other: Frova bougie

Interventions

  • OtherFrova bougie

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

06

What researchers measure

Primary outcomes

  1. Tidal Volume (ml)

    volume of air delivered via Frova bougie (milliliters)

    Time frame: 15 minutes

07

Results

Posted Dec 28, 2018

Participant flow

Participant flow — Overall Study
MilestoneMaximum and Normal Effort Using Long and Short Frova Bougies
Started35
Completed35
Not completed0

Outcome measures

PrimaryTidal Volume (ml)

volume of air delivered via Frova bougie (milliliters)

Time frame:
15 minutes
Reported as:
Mean · tidal volume (ml)
Tidal Volume (ml)
tidal volume (ml)Maximum Effort: LongNormal Effort: LongMaximum Effort: ShortNormal Effort: Short
Tidal Volume (ml)954.8 ± 120.7554.4 ± 131.3893.5 ± 171.6542.9 ± 132.9

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Maximum and Normal Effort Using Long and Short Frova Bougies—0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Maximum and Normal Effort Using Long and Short Frova Bougies
<=18 years0
Between 18 and 65 years35
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Maximum and Normal Effort Using Long and Short Frova Bougies
Female18
Male17
Region of Enrollment
Region of Enrollment(Participants)Maximum and Normal Effort Using Long and Short Frova Bougies
Canada35
08

Study locations

1 site
  • BC Women's Hospital
    Vancouver, British Columbia V5X1T3, Canada
09

References and documents

Publications

  • Dewan P, Taylor J, Gunka V, Albert A, Massey S. Manual volume delivery via Frova Intubating Introducer: a bench research study. Can J Anaesth. 2019 May;66(5):527-531. doi: 10.1007/s12630-019-01308-9. Epub 2019 Feb 12. PubMed 30756337 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02786355
Lead sponsor
University of British Columbia
Responsible party
Simon Massey (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Jun 1, 2016
Start date
Feb 2016
Primary completion
Mar 2016
Completion
Mar 2016
Results posted
Dec 28, 2018
Last update
Dec 28, 2018

Study contacts

Simon Massey, FRCPC
principal investigator · BC Women's Hospital,UBC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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