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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by NHS Grampian.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Research and Development Department, NHS Grampian
University of Aberdeen
Information provided by (Responsible Party):
Lewis Walker, NHS Grampian
ClinicalTrials.gov Identifier:
NCT01029756
First received: December 9, 2009
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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
Anaesthesia
Airway Management
Videolaryngoscopy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lewis Walker, Dr, NHS Grampian
ClinicalTrials.gov 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
Macintosh
Laryngoscope
Video Laryngoscope

ClinicalTrials.gov processed this record on October 29, 2014