NCT00644722

Brief Summary

New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

9 months

First QC Date

March 24, 2008

Last Update Submit

January 27, 2009

Conditions

Cardiac ArrestComaMajor TraumaRespiratory DistressShock

Keywords

IntubationOut-of-hospitalLaryngoscopeBladesEmergency

Outcome Measures

Primary Outcomes (1)

  • Intubation success rate during at the first laryngoscopy

    10 min

Secondary Outcomes (3)

  • glottis exposure assessed by Cormack and Lehane classification

    1 day

  • difficult intubation rate assessed by the Intubation Difficult Score (IDS)

    1 day

  • the need for alternative airway techniques and the immediate post intubation complications rate

    1 day

Study Arms (2)

1

ACTIVE COMPARATOR

Single use metallic blades

Device: MacIntosh Green Lite (metal single use laryngoscope blades)

2

ACTIVE COMPARATOR

Classic reusable metallic blades

Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)

Interventions

MacIntosh Green Lite (metal single use laryngoscope blades)DEVICE

metal single use laryngoscope blades

Also known as: Truphatek company -Israel, Smiths Medical France company
1
MacIntosh Green Spec II (metal reusable laryngoscope blades)DEVICE

metal reusable laryngoscope blades

Also known as: Truphatek company -Israel, Smiths Medical France company
2

Eligibility Criteria

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

You may qualify if:

  • All adult patients requiring out-of-hospital intubation

You may not qualify if:

  • Patient under 18 years old
  • Patients with criteria predictive of impossible intubation under direct laryngoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP

Créteil, Île-de-France Region, 94010, France

Location

MeSH Terms

Conditions

Heart ArrestComaDyspneaShockEmergencies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryPathologic ProcessesDisease Attributes

Study Officials

  • XAVIER COMBES, MD

    Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 27, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

FR(1)