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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by NHS Grampian.
Recruitment status was:  Not yet recruiting
Research and Development Department, NHS Grampian
University of Aberdeen
Information provided by (Responsible Party):
Lewis Walker, NHS Grampian Identifier:
First received: December 9, 2009
Last updated: December 15, 2011
Last verified: December 2011
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 Intervention
Airway Management
Device: Macintosh Laryngoscope
Device: Pentax AWS Videolaryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by NHS Grampian:

Primary Outcome Measures:
  • Is there a clinically significant difference in the time taken to successfully intubate the trachea? [ Time Frame: Following induction of anaesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Is there a difference in the Intubation Difficulty Score? [ Time Frame: Measured at intubation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01029756

United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Grampian, United Kingdom, AB25 2ZN
Sponsors and Collaborators
NHS Grampian
Research and Development Department, NHS Grampian
University of Aberdeen
Principal Investigator: Lewis Walker, MBChB,FRCA Consultant Anaesthetist NHS Grampian
  More Information

Responsible Party: Lewis Walker, Dr, NHS Grampian Identifier: NCT01029756     History of Changes
Other Study ID Numbers: ARI PentaxAWS 10 
Study First Received: December 9, 2009
Last Updated: December 15, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS Grampian:
Pentax Airway Scope AWS S100
Pentax AWS
Video Laryngoscope processed this record on December 09, 2016