NCT02292693

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

Same day

First QC Date

November 12, 2014

Last Update Submit

November 14, 2014

Conditions

Trauma

Keywords

intubation

Outcome Measures

Primary Outcomes (1)

  • Success of intubation

    effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants

    1 day

Secondary Outcomes (3)

  • Intubation time

    1 day

  • Cormack-Lehane grading

    1 day

  • Preferred ETI device

    1day

Study Arms (1)

intubation with immobilized cervical spine

EXPERIMENTAL

endotracheal intubation with immobilized cervical spine

Device: MILDevice: MACDevice: McCoy

Interventions

MILDEVICE

Direct laryngoscopy. Laryngoscopy with Miller blade

intubation with immobilized cervical spine
MACDEVICE

Direct laryngoscopy. Laryngoscopy with Macintosh blade

intubation with immobilized cervical spine
McCoyDEVICE

Direct laryngoscopy. Laryngoscopy with McCoy blade

intubation with immobilized cervical spine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medicine personnel (physicians, nurses, paramedics)

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Lukasz Szarpak

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

PL(1)