A Comparative Study of the Air-Q ILA and the ILMA for Ven... | NCT01209559

Studies
A Comparative Study of the Air-Q ILA and the ILMA for Ventilation and Intubation

NCT01209559

Sponsor

Nova Scotia Health Authority

Status

Withdrawn

Last Update Posted

Jul 18, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Airway Management

Interventions

Not provided

Countries

Canada

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never initiated.

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Sep 23, 2010

First Submission Date that Met QC Criteria

Sep 24, 2010

First Posted Date

Sep 27, 2010Estimated

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

Jul 17, 2018

Last Update Posted Date

Jul 18, 2018Actual

Description Module

Brief Summary

The objective of this study is to determine if the glottic view obtained with the air-Q Intubating Laryngeal Airway (air-Q ILA, Cookgas LLC®, Mercury Medical®, Clearwater, FL, USA) is better than that obtained with the traditionally used intubating laryngeal mask airway (LMA FastrachTM or ILMA, LMA North America Inc., San Diego, CA). The study will also compare effectiveness of ventilation.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy ASA class I and II patients scheduled for elective surgery under general anesthesia requiring the use of the LMA

Exclusion Criteria:

history of acid reflux,
a BMI ≥ 40kg.m-2,
require endotracheal intubation,
have predictors of difficult intubation,
not candidates for insertion of an ILMA or LMA, including a mouth opening of less than 2.5 cm,
cannot consent to the study

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

Healthy ASA class I and II patients scheduled for elective surgery under general anesthesia requiring the use of the LMA.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QEII Health Sciences Centre		Halifax	Nova Scotia	B3H 2Y9	Canada