CMAC® Versus Airtraq® and Macintosh Laryngoscope in Diffi... | NCT01031940

Studies
CMAC® Versus Airtraq® and Macintosh Laryngoscope in Difficult Tracheal Intubation.

NCT01031940

Sponsor

University College Hospital Galway

Status

Terminated

Last Update Posted

Jun 19, 2012Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Airway
Difficult Intubation
Airway Device

Interventions

macintosh laryngoscope
C-MAC laryngoscope
Airtraq device

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient Recruitment. Findings of concurrent study in low risk population not supportive of hypotheses in this study.

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 14, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2012

Last Update Posted Date

Jun 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Laffey, Professor of Anaesthesia, University College Hospital GalwayPrincipal Investigator

Lead Sponsor

University College Hospital GalwayOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present.

The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

The CMAC may be especially effective in situations where intubation of the trachea is potentially difficult.

The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other novel laryngoscopes is not known.

We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard device, in patients with one or more anatomical characteristics predictive of difficult intubation.

The investigators further aim to compare it to the Airtraq® device a device which has been shown to be superior to the Macintosh laryngoscope in previous trials.

The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in patients with two or more anatomical characteristics predictive of difficult intubation.

The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one or more anatomical characteristics predictive of difficult intubation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
macintosh	Active Comparator	Device: macintosh laryngoscope
C-MAC	Active Comparator	Device: C-MAC laryngoscope
Airtraq	Active Comparator	Device: Airtraq device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
macintosh laryngoscope	Device	intubate with the macintosh laryngoscope	macintosh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of successful placement of Tube in the Trachea		immediately

Secondary Outcomes

Measure	Description	Time Frame
1. Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds		immediately
2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1-3 patients undergoing surgical procedures requiring orotracheal intubation.
Written informed Consent
No relevant drug allergies
Patients with 2 or more of the following predictors of difficult intubation:
- Mallampatti II - IV
- Thyromental distance < 6cm
- Mouth opening < 3.5 cm
- Cervical spine disease
- Anteriorly protruding incisors
- Presence of Caps or Crowns

Exclusion Criteria:

Patients with history of or risk factors for gastric regurgitation
Patients unable to consent for the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Galway University Hospital		Galway	Galway		Ireland