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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Other
Condition Failed or Difficult Intubation
Intervention Other: Frova bougie
Enrollment 35
Recruitment Details  
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).
Arm/Group Title Maximum and Normal Effort Using Long and Short Frova Bougies
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title Maximum and Normal Effort Using Long and Short Frova Bougies
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
18
  51.4%
Male
17
  48.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 35 participants
35
 100.0%
1.Primary Outcome
Title Tidal Volume (ml)
Hide Description volume of air delivered via Frova bougie (milliliters)
Time Frame 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maximum Effort: Long Normal Effort: Long Maximum Effort: Short Normal Effort: Short
Hide Arm/Group Description:

Squeeze through long Frova bougie with maximum effort

Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered

Squeeze through long Frova bougie with normal effort

Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered

Squeeze through short Frova bougie with maximum effort

Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered

Squeeze through short Frova bougie with normal effort

Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered

Overall Number of Participants Analyzed 35 35 35 35
Mean (Standard Deviation)
Unit of Measure: tidal volume (ml)
954.8  (120.7) 554.4  (131.3) 893.5  (171.6) 542.9  (132.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maximum and Normal Effort Using Long and Short Frova Bougies
Hide Arm/Group Description

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.

All-Cause Mortality
Maximum and Normal Effort Using Long and Short Frova Bougies
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maximum and Normal Effort Using Long and Short Frova Bougies
Affected / at Risk (%)
Total   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maximum and Normal Effort Using Long and Short Frova Bougies
Affected / at Risk (%)
Total   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Taylor
Organization: UBC Department of Anesthesia - BC Women's Hospital
Phone: 604-875-2424 ext 6076
EMail: james.taylor1@phsa.ca
Layout table for additonal information
Responsible Party: Simon Massey, University of British Columbia
ClinicalTrials.gov Identifier: NCT02786355     History of Changes
Other Study ID Numbers: H15-03391
First Submitted: January 27, 2016
First Posted: June 1, 2016
Results First Submitted: April 27, 2017
Results First Posted: December 28, 2018
Last Update Posted: December 28, 2018