- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07600502
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
McGrath X-blade Study
When patients have a general anaesthetic (go to sleep for surgery), the anaesthetist often places a small tube into their windpipe (intubation) to help them breathe. To see exactly where to put the tube, the anaesthetist uses a device called a laryngoscope.
A commonly used laryngoscope is the McGrath videolaryngoscope. It has a small camera and screen to help guide safe placement of the tube. It comes in two different shapes - one shaped in the same way laryngoscopes have been shaped for the last 80 years, and another newer design (McGrath X-blade) that matches the curve of patients' tongues better.
All different classes of videolaryngoscope have been shown to have benefits to patients; however, the best videolaryngoscope shape has yet to be determined.
The McGrath X-blade is currently recommended in patients in whom the anaesthetist thinks it might be slightly more difficult to place the tube, but some anaesthetists already prefer to use it in all their patients. This is not a new device or a new technique.
In this study, the investigators wish to explore if there is any special benefit of using it in all patients, by collecting some information when the device is used.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrick A Ward
- Phone Number: +44(0)1506523064
- Email: patrick.ward@nhs.scot
Study Contact Backup
- Name: Pamela Milligan
- Phone Number: +44(0)1506523064
- Email: pamela.milligan@nhs.scot
Study Locations
-
-
-
Livingston, United Kingdom
- St John's Hospital
-
Contact:
- Murray Geddes
- Phone Number: +44(0)1506523064
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients undergoing surgical procedures requiring tracheal intubation as part of their routine anaesthetic care
- Patients undergoing either naso- or oro-tracheal intubation
- Patients undergoing tracheal intubation with or without administration of neuromuscular blocking agents (e.g. those undergoing surgery where facial nerve or recurrent laryngeal nerve monitoring will be utilised)
Exclusion Criteria:
- Patients <18 years of age
- Patients in whom tracheal intubation is not required as part of their routine anaesthetic care
- Patients in whom tracheal intubation was not planned as part of their routine anaesthetic care, but was required as a rescue technique (e.g. for failed insertion of a supraglottic airway) since appropriate patient consent will not have been obtained · Patients that are physiologically unstable (where clinical care must take priority and/or patient is unable to consent for inclusion in the study)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Use of McGrath X-blade to facilitate tracheal intubation
Unselected adult patients who have been assessed as requiring tracheal intubation for their surgical intervention/ongoing care, will undergo their intubation procedure facilitated by McGrath X-blade
|
Hyperangulated videolaryngoscopy using McGrath X-blade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-pass success
Time Frame: 5 minutes
|
Incidence of successful tracheal intubation at the first attempt (without complications) using the McGrath-X blade
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall incidence of tracheal intubation success
Time Frame: 5 minutes
|
Overall incidence of tracheal intubation success with the McGrath-X blade without complications (maximum of 3 attempts with the device)
|
5 minutes
|
|
Incidence of complications
Time Frame: 5 minutes
|
Incidence of immediate airway-related complications
|
5 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Patrick A Ward, NHS Lothian
Publications and helpful links
General Publications
- Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9.
- Saul SA, Ward PA, McNarry AF. Airway Management: The Current Role of Videolaryngoscopy. J Pers Med. 2023 Aug 29;13(9):1327. doi: 10.3390/jpm13091327.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 350850
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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