Failed or Difficult IntubationNCT02786355
Oxygenation Via Frova Bougie and Ambu Bag
A study testing Frova bougie in people with Failed or Difficult Intubation, run by University of British Columbia at 1 site in Canada.
Trial summary
We will conduct this study to show that it is possible to deliver air through a Frova bougie and an Ambu® bag. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Failed or Difficult Intubation
- What is being tested?
- Frova bougie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- staff, fellows and resident anesthesiologists
Who cannot join
- injury to hand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Failed or Difficult Intubation
- Being tested
- Frova bougie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frova bougieOther
Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated.
| Study group | Role | What they receive |
|---|---|---|
| Maximum bimanual compression | Other | Squeeze through Frova bougie with maximum bimanual compression Receives: Other: Frova bougie |
| Normal bimanual compression | Other | Squeeze through Frova bougie with normal bimanual compression Receives: Other: Frova bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume (ml)
volume of air delivered via Frova bougie (milliliters)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed or Difficult IntubationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Massey, University of British Columbia
- Investigators
- Simon Massey, FRCPC, Principal investigator, BC Women's Hospital,UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786355
- Sponsor's protocol ID
- H15-03391
- Status last verified
- Jun 2018
- First submitted
- 27 Jan 2016
- Last updated
- 28 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02786355
- Acronym / sponsor ID
- H15-03391
- Conditions
- Failed or Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 28 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximum bimanual compression | Other | Other: Frova bougieSqueeze through Frova bougie with maximum bimanual compression |
| Normal bimanual compression | Other | Other: Frova bougieSqueeze through Frova bougie with normal bimanual compression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- staff, fellows and resident anesthesiologists
Key exclusion criteria (1 listed)
- injury to hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frova bougieSqueezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated. | Other | Maximum bimanual compression, Normal bimanual compression |
Primary outcome
Tidal Volume (ml)
Time frame: 15 minutes
volume of air delivered via Frova bougie (milliliters)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30756337Dewan 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.
- Individual participant dataSharing planned: No
Related trials for Failed or Difficult Intubation
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Massey, FRCPC principal investigator
BC Women's Hospital,UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frova bougie in people with Failed or Difficult Intubation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal Volume (ml) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.