ETI During Intubation

Cardiac Arrest Clinical Trial

— SL  

Official title:

Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: a Randomized Crossover Simulation Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295618
• Other study ID #: ETI/2014/41
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: November 27, 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

The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• 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

• maximum 1 year of work experience in medicine

• maximum 10 clinical intubations

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

• Cardiac Arrest
• Heart Arrest
• Intubation

Intervention

Device:
• Standard tracheal tube
Intubation using Macintosh laryngoscope and standard tracheal tube
• ETView VivaSight SL
Intubation using ETView VivaSight SL

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.	1 day	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.	1 day	No
Secondary	Cormack-Lehan scale	self reported Cormack-Lehan scale during intubation	1 day	No