Algorithms in a Simulated Difficult Intubation Scenario | NCT00951769

Studies
Algorithms in a Simulated Difficult Intubation Scenario

NCT00951769

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Jun 9, 2022Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Airway Management

Interventions

Not provided

Countries

United Kingdom

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

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Aug 3, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 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 6, 2022

Last Update Posted Date

Jun 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a non-human study, conducted in a simulation environment, with simulator manikins, and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training will be randomised to a control group, a group following the Difficult Airway Society UK's Guidelines and the Australian Difficult Airway management algorithm. A simulated difficult airway will be created during the induction of anaesthesia. The investigators will examine adherence to guidelines, which would have been provided to participants before the experiment, as well as compare their performance with the guidelines.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control,		Control
DAS: Difficult Airway Society, UK		DAS difficult airway algorithm
Australian		Australian difficult airway algorithm

Interventions

Not provided

Measure	Description	Time Frame
Time to safe oxygenation for manikin		Variable

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anaesthetists in first 2 years of training

Exclusion Criteria:

Those who decline invitation to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Trainee anaesthetists in for 2 years of training

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ARPAN GUHA, MD, FRCA	AINTREE HOSPITALS NHS TRUST	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cheshire & Merseyside Simulation Centre		Liverpool	Merseyside	L9 7AL	United Kingdom