ClinicalTrials.gov
ClinicalTrials.gov Menu

Ventilation Using a Bag Valve Mask With Supplemental External Handle

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: NCT02800213
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Michael D. April, Brooke Army Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Apnea
Interventions Device: Modified Ambu Spur II bag valve mask
Device: Conventional Ambu Spur II bag valve mask
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Modified Then Conventional Ambu Spur II Bag Valve Mask Conventional Then Modified Ambu Spur II Bag Valve Mask
Hide Arm/Group Description

A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.

After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.

A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask

After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.

Period Title: First Intervention
Started 35 35
Completed 35 35
Not Completed 0 0
Period Title: Second Intervention
Started 35 35
Completed 35 35
Not Completed 0 0
Arm/Group Title Modified Then Conventional Ambu Spur II Bag Valve Mask Conventional Then Modified Ambu Spur II Bag Valve Mask Total
Hide Arm/Group Description

A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.

After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.

A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.

After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.

Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
35
 100.0%
70
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female 16 16 32
Male 19 19 38
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 70 participants
35 35 70
1.Primary Outcome
Title Received Tidal Volume
Hide Description Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.
Time Frame 3 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Ambu Spur II Bag Valve Mask Conventional Bag Valve Mask
Hide Arm/Group Description:

A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.

After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.

A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.

After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.

Overall Number of Participants Analyzed 70 70
Mean (95% Confidence Interval)
Unit of Measure: milliliters
662
(611 to 707)
681
(635 to 731)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modified Ambu Spur II Bag Valve Mask, Conventional Bag Valve Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 hour
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modified Ambu Spur II Bag Valve Mask Conventional Ambu Spur II Bag Valve Mask
Hide Arm/Group Description

A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.

After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.

A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).

Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.

After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.

All-Cause Mortality
Modified Ambu Spur II Bag Valve Mask Conventional Ambu Spur II Bag Valve Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Modified Ambu Spur II Bag Valve Mask Conventional Ambu Spur II Bag Valve Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modified Ambu Spur II Bag Valve Mask Conventional Ambu Spur II Bag Valve Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (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
Name/Title: Dr. Michael D. April
Organization: San Antonio Uniformed Services Health Education Consortium
Phone: 2109160808 ext 210
Responsible Party: Michael D. April, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02800213     History of Changes
Other Study ID Numbers: C.2016.136e
First Submitted: June 12, 2016
First Posted: June 15, 2016
Results First Submitted: March 22, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017