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Trial record 10 of 42 for:    FROVATRIPTAN

Oxygenation Via Frova Bougie and Ambu Bag

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786355
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Simon Massey, University of British Columbia

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE June 1, 2016
Results First Submitted Date  ICMJE April 27, 2017
Results First Posted Date  ICMJE December 28, 2018
Last Update Posted Date December 28, 2018
Study Start Date  ICMJE February 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
Tidal Volume (ml) [ Time Frame: 15 minutes ]
volume of air delivered via Frova bougie (milliliters)
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Tidal Volume (ml) [ Time Frame: 2 weeks ]
volume of air delivered via Frova bougie (milliliters)
Change History Complete list of historical versions of study NCT02786355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxygenation Via Frova Bougie and Ambu Bag
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Failed or Difficult Intubation
Intervention  ICMJE Other: Frova bougie
Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated.
Study Arms  ICMJE
  • Maximum bimanual compression
    Squeeze through Frova bougie with maximum bimanual compression
    Intervention: Other: Frova bougie
  • Normal bimanual compression
    Squeeze through Frova bougie with normal bimanual compression
    Intervention: Other: Frova bougie
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • staff, fellows and resident anesthesiologists

Exclusion Criteria:

  • injury to hand
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786355
Other Study ID Numbers  ICMJE H15-03391
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Simon Massey, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Massey, FRCPC BC Women's Hospital,UBC
PRS Account University of British Columbia
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP