NCT00847184

Brief Summary

Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

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

February 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

February 11, 2009

Last Update Submit

February 18, 2009

Conditions

Tracheal Intubation

Keywords

nasal intubationAitraqdifficult intubation

Outcome Measures

Primary Outcomes (1)

  • Time for intubation

    10 month

Secondary Outcomes (1)

  • Success rate for intubation

    10 month

Study Arms (2)

1. Airtraq

ACTIVE COMPARATOR

Intubation with the use of the Airtraq technique

Device: Airtraq

2. MacIntosh

ACTIVE COMPARATOR

Intubation using the standard MacIntosh blade

Device: Intubation

Interventions

IntubationDEVICE

Intubation using the standard MacIntosh blade

2. MacIntosh
AirtraqDEVICE

Intubation with the use of the Airtraq technique

Also known as: Aitraq, Prodol Meditec S.A., Vizcaya, Spain
1. Airtraq

Eligibility Criteria

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

You may qualify if:

  • Scheduled for nasal intubation
  • Adult

You may not qualify if:

  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Harald Groeben

Essen, 45136, Germany

RECRUITING

Related Publications (1)

  • Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.

    PMID: 16674623BACKGROUND

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Harald Groeben, M.D.

    Kliniken Essen-Mitte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

DE(1)