NCT02786355

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 28, 2018

Completed
Last Updated

December 28, 2018

Status Verified

June 1, 2018

Enrollment Period

29 days

First QC Date

January 27, 2016

Results QC Date

April 27, 2017

Last Update Submit

June 18, 2018

Conditions

Failed or Difficult Intubation

Outcome Measures

Primary Outcomes (1)

  • Tidal Volume (ml)

    volume of air delivered via Frova bougie (milliliters)

    15 minutes

Study Arms (2)

Maximum bimanual compression

OTHER

Squeeze through Frova bougie with maximum bimanual compression

Other: Frova bougie

Normal bimanual compression

OTHER

Squeeze through Frova bougie with normal bimanual compression

Other: Frova bougie

Interventions

Frova bougieOTHER

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

Maximum bimanual compressionNormal bimanual compression

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • staff, fellows and resident anesthesiologists

You may not qualify if:

  • injury to hand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V5X1T3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30756337DERIVED

Results Point of Contact

Title
James Taylor
Organization
UBC Department of Anesthesia - BC Women's Hospital
james.taylor1@phsa.ca
604-875-2424

Study Officials

  • Simon Massey, FRCPC

    BC Women's Hospital,UBC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2016

First Posted

June 1, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 28, 2018

Results First Posted

December 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)