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NCT02292693 Clinical Trial

Direct Laryngoscopy During Cervical Trauma

Trauma Clinical Trial

Official title:
Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02292693
Other study ID # ETI/2014/18
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 12, 2014
Last updated November 14, 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 aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
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 medicine personnel (physicians, nurses, paramedics)

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:
• MIL
Direct laryngoscopy. Laryngoscopy with Miller blade
• MAC
Direct laryngoscopy. Laryngoscopy with Macintosh blade
• McCoy
Direct laryngoscopy. Laryngoscopy with McCoy blade

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 Success of intubation effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants 1 day No
Secondary Intubation time time in seconds required for a successful intubation attempt 1 day No
Secondary Cormack-Lehane grading self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) 1 day No
Secondary Preferred ETI device participants were asked which method of ETI they would prefer in a real-life resuscitation. 1day No
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