Randomised Controlled Trial of Intubation, Comparing Pentax AWS Against Macintosh Laryngoscope.
PAWS
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.
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 16, 2011
December 1, 2011
8 months
December 9, 2009
December 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Is there a clinically significant difference in the time taken to successfully intubate the trachea?
Following induction of anaesthesia
Secondary Outcomes (1)
Is there a difference in the Intubation Difficulty Score?
Measured at intubation
Study Arms (2)
Macintosh Laryngoscope
ACTIVE COMPARATORPentax AWS Videolaryngoscope
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Grampianlead
- Research and Development Department, NHS Grampiancollaborator
- University of Aberdeencollaborator
Study Sites (1)
Aberdeen Royal Infirmary
Aberdeen, Grampian, AB25 2ZN, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Lewis Walker, MBChB,FRCA
Consultant Anaesthetist NHS Grampian
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 10, 2009
Study Start
January 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 16, 2011
Record last verified: 2011-12