NCT02681835

Brief Summary

We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

29 days

First QC Date

February 10, 2016

Last Update Submit

March 8, 2016

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Time required for successful intubation

    1 day

Secondary Outcomes (5)

  • success rate of intubation attempt

    1 day

  • cumulative success ratios related to time

    1 day

  • Ease of intubation

    1 day

  • Cormack&Lehane grade

    1 day

  • Dental Compression

    1 day

Study Arms (3)

Position 1

EXPERIMENTAL

Standard position during intubation. Intubator is behind head of the victim, propped up on both elbows

Device: C-MAC laryngoscopeDevice: Macintosh laryngoscope

Position 2

EXPERIMENTAL

Intubator is behind head of the victim, lies on the left side

Device: C-MAC laryngoscopeDevice: Macintosh laryngoscope

Position 3

EXPERIMENTAL

Intubator stands astride the victims, intubated using the face-to-face

Device: C-MAC laryngoscopeDevice: Macintosh laryngoscope

Interventions

C-MAC laryngoscopeDEVICE

Intubation performed using C-MAC laryngoscope

Also known as: C-MAC
Position 1Position 2Position 3
Macintosh laryngoscopeDEVICE

Intubation performed using laryngoscope with Macintosh blade

Also known as: C-MAC
Position 1Position 2Position 3

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
  • maximum 1 year of work experience in medicine
  • minimum 50 clinical intubations
  • 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)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

Location

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
Principal Investigator

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

PL(1)