NCT01122433

Brief Summary

The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

May 5, 2010

Last Update Submit

September 27, 2010

Conditions

Unexpected Difficult Airway

Keywords

difficult airwayindirect laryngoscopyC-MAC video laryngoscope

Outcome Measures

Primary Outcomes (1)

  • Success rate of endotracheal intubation using the C-MAC video laryngoscope

    The investigators evaluate the C-MAC as an alternative after failed direct laryngoscopy. Primary outcome measure is the success rate using the C-MAC video laryngoscope in unexpected difficult airways.

Secondary Outcomes (4)

  • - improved glottic view

  • - complications

  • - numbers of intubation attempts

  • - size of blade (C-MAC)

Study Arms (1)

C-MAC

EXPERIMENTAL

After a maximum of three failed intubation attempts using direct laryngoscope the C-MAC video laryngoscope is used as an emergency airway device.

Device: Endotracheal intubation using the C-MAC video laryngoscope

Interventions

Endotracheal intubation using the C-MAC video laryngoscopeDEVICE

Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy

C-MAC

Eligibility Criteria

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

You may qualify if:

  • Unexpected difficult airway

You may not qualify if:

  • History of difficult or impossible mask ventilation
  • Age \< 18 years
  • ASA grade \> 3
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeritätsmedizin of the JG University, Department of Anaesthesiology

Mainz, 55131, Germany

Location

Study Officials

  • Tim Piepho, MD

    Department of Anaesthesiology, Universitätsmedizin Mainz

    PRINCIPAL INVESTIGATOR

  • Rüdiger R Noppens, MD

    Department of Anaesthesiology, Universitätsmedizin Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 13, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

DE(1)