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Randomised Controlled Trial of Intubation, Comparing Pentax AWS Against Macintosh Laryngoscope. (PAWS)

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ClinicalTrials.gov Identifier: NCT01029756
Recruitment Status : Unknown
Verified December 2011 by Lewis Walker, NHS Grampian.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2009
Last Update Posted : December 16, 2011
Sponsor:
Collaborators:
Research and Development Department, NHS Grampian
University of Aberdeen
Information provided by (Responsible Party):
Lewis Walker, NHS Grampian

Brief Summary:
A randomised controlled trial of intubation by inexperienced anaesthetists, comparing the The Pentax Airway Scope AWS-S100 Rigid Video Laryngoscope(Pentax AWS) and the Macintosh Laryngoscope.

Condition or disease Intervention/treatment
Anaesthesia Airway Management Videolaryngoscopy Device: Macintosh Laryngoscope Device: Pentax AWS Videolaryngoscope

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomised Controlled Trial of Intubation by Inexperienced Anaesthetists, Comparing the The Pentax Airway Scope AWS-S100 Rigid Video Laryngoscope(Pentax AWS) and the Macintosh Laryngoscope.
Study Start Date : January 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: Macintosh Laryngoscope Device: Macintosh Laryngoscope
Device used to gain a direct view of the vocal cords, to enable an endotracheal tube to be passed into the trachea at induction of anaesthesia.
Other Name: Direct laryngoscopy
Active Comparator: Pentax AWS Videolaryngoscope Device: Pentax AWS Videolaryngoscope
Self-contained video laryngoscope with an integral colour-viewing screen mounted on the handle. A camera at the tip transmits an indirect image, which obviates the need to obtain a direct view of the vocal cords, when passing an endotracheal tube on induction of anaesthesia.
Other Name: Videolaryngoscopy



Primary Outcome Measures :
  1. Is there a clinically significant difference in the time taken to successfully intubate the trachea? [ Time Frame: Following induction of anaesthesia ]

Secondary Outcome Measures :
  1. Is there a difference in the Intubation Difficulty Score? [ Time Frame: Measured at intubation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults (18 years and over)
  • scheduled for elective surgery whose anaesthetic plan would normally include oral intubation using a Macintosh laryngoscope blade by a junior anaesthetist and who have given valid informed consent.

Exclusion Criteria:

  • Patients requiring special techniques for intubation such as awake fibreoptic intubation.
  • Unconscious or critically ill patients.
  • Emergency situations.
  • Vulnerable patients including patients with:

    • learning difficulties,
    • terminal illness, mental illness, dementia,
    • prisoners and
    • those who could be considered to have a particularly dependent relationship with the investigator(such as medical students).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029756


Contacts
Contact: Lewis Walker, MBChB, FRCA 01224553144 lewis.walker@nhs.net
Contact: Robert A Lendrum, MBChB, FRCA 01224553142 rlendrum@nhs.net

Locations
United Kingdom
Aberdeen Royal Infirmary Not yet recruiting
Aberdeen, Grampian, United Kingdom, AB25 2ZN
Contact: Lewis Walker, MBChB, FRCA    01224553144    lewis.walker@nhs.net   
Contact: Robert A Lendrum, MBChB, FRCA    01224553142    rlendrum@nhs.net   
Sponsors and Collaborators
NHS Grampian
Research and Development Department, NHS Grampian
University of Aberdeen
Investigators
Principal Investigator: Lewis Walker, MBChB,FRCA Consultant Anaesthetist NHS Grampian

Responsible Party: Lewis Walker, Dr, NHS Grampian
ClinicalTrials.gov Identifier: NCT01029756     History of Changes
Other Study ID Numbers: ARI PentaxAWS 10
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by Lewis Walker, NHS Grampian:
Pentax Airway Scope AWS S100
Pentax AWS
Macintosh
Laryngoscope
Video Laryngoscope