Randomised Controlled Trial of Intubation, Comparing Pentax AWS Against Macintosh Laryngoscope. (PAWS)
This study is not yet open for participant recruitment.
Verified December 2011 by NHS Grampian
Sponsor:
NHS Grampian
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
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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
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 May 23, 2013