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NCT02286323 Clinical Trial

Endotracheal Intubation During Resuscitation

Cardiac Arrest Clinical Trial

— EIDR  

Official title:
Can the Bonfils Intubation Fiberscope Rival the Macintosh Laryngoscope During Resuscitation With Uninterrupted Chest Compression?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02286323
Other study ID # ETI/2014/07
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 5, 2014
Last updated November 7, 2014
Start date November 2014
Est. completion date November 2014

Study information
Verified date November 2014
Source International Institute of Rescue Research and Education
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial Summary

We hypothesized that the BONFILS is beneficial for intubation of manikins while performing CPR. In the current study we compared the performance of the BONFILS and the Macintosh laryngoscopes with respect to their effectiveness and time to successful ETI during chest compression (CC) using an adult manikin.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 130
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- give voluntary consent to participate in the study

- minimum 1 year of work experience in emergency medicine

- experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

- not meet the above criteria

- wrist or low back diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Bonfils
Bonfils Intubation Fiberoscope
• Macintosh
Direct laryngoscopy using Macintosh Laryngoscope

Locations
Country Name City State
Poland International Institute of Rescue Research and Education Warsaw Masovia

Sponsors (1)
Lead Sponsor Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to intubation time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure. intraoperative No
Secondary Success of intubation effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations. intraoperative No
Secondary POGO score self-reported percentage of glottis opening (POGO) score 1 day No
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