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Videolaryngoscopy in Patients With Cervical Spine Immobilisation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563301
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Lynsey Foulds, NHS Tayside

Brief Summary:

Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.

The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.


Condition or disease Intervention/treatment Phase
Intubation; Difficult Device: Laryngoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation
Study Start Date : August 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: McGrath Series 5
Videolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation
Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.

Active Comparator: Macintosh
Laryngoscope used to perform direct laryngoscopy and tracheal intubation
Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.




Primary Outcome Measures :
  1. Cormack and Lehane laryngoscopy grade [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. Time to intubation [ Time Frame: 5 minutes ]
  2. Rate of successful tracheal intubation [ Time Frame: 5 minutes ]
  3. Incidence of complications [ Time Frame: 5 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective procedure requiring tracheal intubation
  • Over 16 years of age

Exclusion Criteria:

  • Emergency procedure
  • Less than 16 years of age
  • Unable to consent
  • Symptomatic gastro-oesophageal reflux disease
  • Evidence of raised intracranial pressure
  • Known pharyngeal pathology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563301


Locations
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United Kingdom
NHS Tayside
Tayside, United Kingdom
Sponsors and Collaborators
NHS Tayside
Investigators
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Principal Investigator: Lynsey T Foulds, MBChB NHS Tayside
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Responsible Party: Lynsey Foulds, Specialty Registrar Anaesthetics, NHS Tayside
ClinicalTrials.gov Identifier: NCT02563301    
Other Study ID Numbers: 2008AN01
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015